Gon 74

STAATSKOERANT, 6 FEBRUARIE 2013 No.
36136 3
GOVERNMENT NOTICE
GOEWERMENTSKENNISGEWING
DEPARTMENT OF HEALTH
DEPARTEMENT VAN GESONDHEID
No. 74 6 February 2013
MEDICINES CONTROL COUNCIL

CONDITIONS OF REGISTRATION OF A MEDICINE IN TERMS OF THE PROVISIONS
OF SECTION 15(7) OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965
(ACT 101 OF 1965)
1. The applicant shall ensure that the medicine is manufactured and controlled in
terms of the current Good Manufacturing Practices as determined by Council
2. The manufacture of this medicine is subject to regular investigation and
inspections by the inspectors appointed in terms of Section 26 of the Act, to
assess compliance with current Good Manufacturing Practices.
3. The information in the package insert shall be updated on a regular basis to
conform to the package insert recently approved by Council.
4. The applicant must comply with all the legal requirements of the Medicines and
Related Substances Act, 1965 (Act 101 of 1965).
5. The registration of this medicine shall be subject to review at intervals as
determined by Council regarding its quality, safety and efficacy, and the
registration of this medicine may be varied subject to issues Council may deem
fit.
6. The first two production batches must be fully validated in terms of the detailed
process validation protocol submitted at the time of application for registration,
and the validation report must be submitted within a month after completion of
the validation.
7. The product may be advertised to the professions only.
8. The provisional shelf-life allocated must be confirmed with stability data over the
full shelf-life period on the first two production batches (well-known API) or first
three production batches (NCE) in accordance with the Stability Guideline.
Stability testing submitted on any pilot batches must also be completed and
reported, on. The stability report must be submitted within six months after
completion of the stability trial. However, Council has to be informed immediately
if any parameter shows a significant change or out-of-specification result during
the stability trial.
9. A post-registration inspection must be conducted on the first production batch
manufactured by each local manufacturer.
10. A post-registration inspection must be conducted on the first production batch of
the imported product.
11. Marketing of the product may only commence following a satisfactory post-
registration inspection report.
12. One sample of every batch, together with four copies of the protocol for testing of
the bulk lot and filling lot, and six copies of the certificate of release issued by a
competent authority in the country in which the product was manufactured, must
be submitted to the Council for lot release purposes.
13. The expiry date allocated shall be modified by adding a statement that the virus
strains are currently recommended for South African usage in the specific year.
14. The strains of the master seed viruses must be approved by the Department of
Health for each year.
MRF 15 MRF15 F 15
Registration number: 07/13.3.1/24 Registration number: A39/20.2.2/0589 Registration number: A39/7.1/0590

Name of medicine: CORTAVANCE Name of medicine: CANESTEN 3VC Name of medicine: ASPEN NIMODIPINE IV
Dosage form: CUTANEOUS SPRAY SOLUTION Dosage form: VAGINAL CREAM Dosage form: INFUSION
Active ingredients: EACH 1,0 ml SOLUTION CONTAINS: Active ingredients: EACH 1,0 g CREAM CONTAINS: Active ingredients: EACH 50,0 ml SOLUTION CONTAINS:
Hydrocortisone aceponate 0,584 mg CLOTRIMAZOLE 20,0 mg NIMODIPINE 10,0 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8
Applicant: VIRBAC RSA (PTY) LTD Applicant: BAYER (PTY) LTD Applicant: PHARMACARE LIMITED
Manufacturer: VIRBAC S.A, CARROS, CEDEX, FRANCE Manufacturer: KERN PHARMA SL, TERASSA, Manufacturer: LABORATORIO REIG JOFRE, S.A,
BARCELONA, SPAIN BARCELONA, SPAIN
STRIDES ARCOLAB LIMITED,
BANNERGHATTA, BANGALORE, INDIA
Packer: VIRBAC S.A, CARROS, CEDEX, FRANCE Packer: KERN PHARMA SL, TERASSA, Packer: LABORATORIO REIG JOFRE, S.A,
VIRBAC RSA, CENTURION, RSA BARCELONA, SPAIN BARCELONA, SPAIN
AKACIA PHARMACEUTICALS, ISANDO, STRIDES ARCOLAB LIMITED,
RSA BANNERGHATTA, BANGALORE, INDIA
DIVPHARM MANUFACTURING AND
PACKAGING (PTY) LTD, LONGDALE,
INDUSTRIA, RSA
SPECPHARM HOLDINGS, HALFWAY
HOUSE, MIDRAND, RSA
PHARMA-Q, INDUSTRIA WEST,
JOHANNESBURG, RSA
PHARMACEUTICAL CONTRACTORS,
ISANDO, JOHANNESBURG, RSA
Laboratory: FPRC: VIRBAC S.A, CARROS, CEDEX, FRANCE Laboratory: FPRC: KERN PHARMA SL, TERASSA, Laboratory: FPRC: LABORATORIO REIG JOFRE, S.A,
M&L LABORATORY SERVICES (PTY) LTD, BARCELONA, SPAIN BARCELONA, SPAIN
ORMONDE, JOHANNESBURG, RSA AKACIA PHARMACEUTICALS, ISANDO, STRIDES ARCOLAB LIMITED,
RSA BANNERGHATTA, BANGALORE, INDIA
SABS COMMERCIAL (PTY) LTD SABS COMMERCIAL (PTY) LTD,
PHARMACEUTICAL CHEMISTRY PHARMACEUTICAL CHEMISTRY
DEPARTMENT, GROENKLOOF, DEPARTMENT, GROENKLOOF, PRETORIA,
PRETORIA, RSA RSA
RESEARCH INSTITUTE FOR INDUSTRIAL RESEARCH INSTITUTE FOR INDUSTRIAL
PHARMACY, NORTH WEST UNIVERSITY, PHARMACY,NORTH-WEST UNIVERSITY,
POTCHEFSTROOM, RSA POTCHEFSTROOM, RSA
SPECPHARM HOLDINGS, HALFWAY PHARMACARE LIMITED, KORSTEN, PORT
HOUSE, MIDRAND, RSA ELIZABETH, RSA
STAATSKOERANT, 6 FEBRUARIE 2013
PHARMA-Q, INDUSTRIA WEST, ASPEN PHARMACARE EAST LONDON,

JOHANNESBURG, RSA WILSONIA, EAST LONDON, RSA
PHARMACEUTICAL CONTRACTORS,
ISANDO, JOHANNESBURG, RSA
FPRR: VIRBAC RSA (PTY) LTD, CENTURION, RSA FPRR: BAYER (PTY) LTD, ISANDO, FPRR: PHARMACARE LIMITED, WOODMEAD,
JOHANNESBURG, RSA SANDTON, RSA
Shelf-life: 24 months Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional)
In-use shelf life of 6 months stored at or below
25 °C or between
2 -8 °C
Date of registration: 26 OCTOBER 2012 Date of registration: 26 OCTOBER 2012 Date of registration: 26 OCTOBER 2012
No. 36136
5
6
No. 36136
MRF 15 MRF15 F 15
Registration number: A40/11.4.3/0153 Registration number: 41/3.1/0252 Registration number: 41/3.1/0253

Name of medicine: COVAN LANSOPRAZOLE 15 Name of medicine: Name of medicine:
MEDOXICAM 7,5 MEDOXICAM 15
Dosage form: CAPSULE Dosage form: TABLET Dosage form: TABLET
Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS:
LANSOPRAZOLE 15,0 mg MELOXICAM 7,5 mg MELOXICAM 15,0 mg
Conditions of registration: Conditions of registration: Conditions of registration:
1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7
Applicant: ADCOCK INGRAM LIMITED Applicant: SPECPHARM (PTY) LTD Applicant: SPECPHARM (PTY) LTD
Manufacturer: Manufacturer: Manufacturer:
LICONSA S.A., GUADALAJARA, MEDOCHEMIE LTD, LIMASSOL, MEDOCHEMIE LTD, LIMASSOL,
SPAIN CYPRUS CYPRUS
Packer: Packer: Packer:
LICONSA S.A., GUADALAJARA, MEDOCHEMIE LTD, LIMASSOL, MEDOCHEMIE LTD, LIMASSO
SPAIN CYPRUS CYPRUS
Laboratory: FPRC: LICONSA S.A., GUADALAJARA, Laboratory: FPRC: Laboratory: FPRC:
MEDOCHEMIE LTD, LIMASSOL, MEDOCHEMIE LTD, LIMASSOL,
SPAIN CYPRUS CYPRUS
FPRC/FPRR: ADCOCK INGRAM FPRR: FPRR:
SPECPHARM (PTY) LTD, HALFWAY SPECPHARM (PTY) LTD,
HEALTHCARE, WADEVILLE, HOUSE, MIDRAND, RSA HALFWAY HOUSE, MIDRAND,
GERMISTON, RSA RSA
ADCOCK INGRAM
HEALTHCARE, CLAYVILLE,
OLIFANTSFONTEIN, RSA
FPRR: ADCOCK INGRAM LIMITED, Shelf-life: Shelf-life:
24 months 24 months
ERAND GARDENS, MIDRAND,
RSA
GOVERNMENT GAZETTE, 6 FEBRUARY 2013
Shelf-life: 24 months Date of registration: Date of registration:

26 OCTOBER 2012 26 OCTOBER 2012
Date of registration: 26 OCTOBER 2012

MRF 15 MRF15 VIRF 15
Registration 41/7.1.3/0770 Registration number: 41/7.1.3/0771 Registration number: 42/8.2/0193

number:
Name of medicine: EXFORGE 5/320 mg Name of medicine: EXFORGE 10/320 mg Name of medicine: ENOXAPARIN SODIUM 20 WINTHROP
Dosage form: TABLET Dosage form: TABLET Dosage form: INJECTION
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH 0,2 ml SOLUTION CONTAINS:
Amlodipine besylate equivalent to Amlodipine besylate equivalent to ENOXAPARIN SODIUM 20,0 mg
Amlodipine 5,0 mg Amlodipine 10,0 mg
Valsartan 320,0 mg Valsartan 320,0 mg
Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7
registration: registration:
SANOFI-AVENTIS SOUTH AFRICA (PTY)
Applicant: NOVARTIS SA (PTY) LTD Applicant: NOVARTIS SA (PTY) LTD Applicant: LTD
Manufacturer: NOVARTIS PHARMA STEIN AG, Manufacturer: NOVARTIS PHARMA STEIN AG, Manufacturer: AVENTIS INTERNATIONAL, MAISONS-
STEIN, SWITZERLAND STEIN, SWITZERLAND ALFORT-CEDEX, FRANCE
AVENTIS PHARMA LE TRAIT, LE TRAIT,
FRANCE
Packer: NOVARTIS PHARMA STEIN AG, Packer: NOVARTIS PHARMA STEIN AG, Packer: AVENTIS INTERNATIONAL, MAISONS-
ALLPACK AG, REINACH, ALLPACK AG, REINACH, AVENTIS PHARMA LE TRAIT, LE TRAIT,
SWITZERLAND SWITZERLAND FRANCE
SANDOZ SA (PTY) LTD, SPARTAN, SANDOZ SA (PTY) LTD, SPARTAN, WINTHROP PHARMACEUTICALS,
KEMPTON PARK, RSA KEMPTON PARK, RSA WALTLOO, PRETORIA, RSA
KONAPHARMA AG, PRATTELN, KONAPHARMA AG, PRATTELN,
SWITZERLAND SWITZERLAND
IVERS-LEE AG, BURGDORF, IVERS-LEE AG, BURGDORF,
Laboratory: F.PRC: NOVARTIS PHARMA STEIN AG, Laboratory: FPRC: NOVARTIS PHARMA STEIN AG, Laboratory: FPRC AVENTIS INTERNATIONAL, MAISONS-
NOVARTIS PHARMANALYTICA SA, NOVARTIS PHARMANALYTICA SA, AVENTIS PHARMA LE TRAIT, LE TRAIT,
LOCARNO, SWITZERLAND LOCARNO, SWITZERLAND FRANCE
SANDOZ SA (PTY) LTD, SPARTAN, SANDOZ SA (PTY) LTD, SPARTAN,
KEMPTON PARK, RSA KEMPTON PARK, RSA
M&L LABORATORY SERCICES M&L LABORATORY SERCICES
(PTY) LTD, LIMBRO BUSINESS (PTY) LTD, LIMBRO BUSINESS

PARK, SANDTON, RSA PARK, SANDTON, RSA
FPRR: NOVARTIS SA (PTY) LTD, FPRR: NOVARTIS SA (PTY) LTD, WINTHROP
FPRC/FPRR:
SPARTAN, KEMPTON PARK, RSA SPARTAN, KEMPTON PARK, RSA PHARMACEUTICALS
WALTLOO, PRETORIA
Shelf-life: 24 months Shelf-life: 24 months FPRR: SANOFI-AVENTIS S.A., MIDRAND, RSA

Date of 26 OCTOBER 2012 Date of registration: 26 OCTOBER 2012 Shelf-life: 24 months
registration:
Date of registration 26 OCTOBER 2012

No. 36136
7
8
MRF 15 MRF15 V1RF 15
Registration 42/8.2/0194 Registration number: 42/8.2/0195 Registration number: 42/8.2/0196

No. 36136
number:
Name of medicine: ENOXAPARIN SODIUM 40 WINTHROP Name of medicine: ENOXAPARIN SODIUM 60 Name of medicine: ENOXAPARIN SODIUM 80
WINTHROP WINTHROP
Dosage form: INJECTION Dosage form: INJECTION Dosage form: INJECTION
Active ingredients: EACH 0,4 ml SOLUTION CONTAINS: Active ingredients: EACH 0,6 ml SOLUTION Active ingredients: EACH 0,8 ml SOLUTION
ENOXAPARIN SODIUM 40,0 mg CONTAINS: CONTAINS:
ENOXAPARIN SODIUM 60,0 mg ENOXAPARIN SODIUM 80,0 mg
Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7
SANOFI-AVENTIS SOUTH AFRICA SANOFI-AVENTIS SOUTH AFRICA SANOFI-AVENTIS SOUTH
Applicant: (PTY) LTD Applicant: (PTY) LTD Applicant: AFRICA (PTY) LTD
Manufacturer: AVENTIS INTERNATIONAL, MAISONS- Manufacturer: AVENTIS INTERNATIONAL, Manufacturer: AVENTIS INTERNATIONAL,
ALFORT-CEDEX, FRANCE MAISONS-ALFORT-CEDEX, MAISONS-ALFORT-CEDEX,
AVENTIS PHARMA LE TRAIT, LE FRANCE FRANCE
TRAIT, FRANCE AVENTIS PHARMA LE TRAIT, LE AVENTIS PHARMA LE TRAIT, LE
TRAIT, FRANCE TRAIT, FRANCE
Packer: AVENTIS INTERNATIONAL, MAISONS- Packer: AVENTIS INTERNATIONAL, Packer: AVENTIS INTERNATIONAL,
WINTHROP PHARMACEUTICALS, TRAIT, FRANCE TRAIT, FRANCE
WALTLOO, PRETORIA, RSA WINTHROP PHARMACEUTICALS, WINTHROP
WALTLOO, PRETORIA, RSA PHARMACEUTICALS, WALTLOO,
PRETORIA, RSA
Laboratory: FPRC: AVENTIS INTERNATIONAL, MAISONS- Laboratory: FPRC: AVENTIS INTERNATIONAL, Laboratory: FPRC: AVENTIS INTERNATIONAL,
TRAIT, FRANCE TRAIT, FRANCE
FPRC/FPRR: WINTHROP PHARMACEUTICALS FPRC/FPRR: WINTHROP PHARMACEUTICALS FPRC/FPRR WINTHROP PHARMACEUTICALS
WALTLOO, PRETORIA WALTLOO, PRETORIA WALTLOO, PRETORIA
FPRR: SANOFI-AVENTIS S.A., MIDRAND, RSA FPRR: SANOFI-AVENTIS S.A., MIDRAND, FPRR: SANOFI-AVENTIS S.A.,
RSA MIDRAND, RSA
Shelf-life: 24 months Shelf-life: 24 months Shelf-life: 24 months
Date of 26 OCTOBER 2012 Date of registration: 26 OCTOBER 2012 Date of registration: 26 OCTOBER 2012
registration:
300399—B
MRF 15 MRF15 F15
Registration number: 42/8.2/0197 Registration 42/8.2/0198 Registration number: 42/20.1.2/0212

number:
Name of medicine: ENOXAPARIN SODIUM 100 WINTHROP Name of medicine: ENOXAPARIN SODIUM 300 WINTHROP Name of medicine: CLAMGEN IV 0,6
Dosage form: INJECTION Dosage form: INJECTION Dosage form: INJECTION
Active ingredients: EACH 1,0 ml SOLUTION CONTAINS: Active ingredients: EACH 3,0 ml SOLUTION CONTAINS: Active ingredients: EACH VIAL CONTAINS:
ENOXAPARIN SODIUM 100,0 mg ENOXAPARIN SODIUM 300,0 mg AMOXICILLIN SODIUM EQUIVALENT TO
AMOXICILLIN 500,0 mg
POTASSIUM CLAVULANATE EQUIVALENT TO
CLAVULANIC ACID 100,0 mg
Conditions of registration' 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7
registration:
SANOFI-AVENTIS SOUTH AFRICA SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD
Applicant: (PTY) LTD Applicant: Applicant: XIXIA PHARMACEUTICALS (PTY) LTD
Manufacturer: AVENTIS INTERNATIONAL, MAISONS- Manufacturer: AVENTIS INTERNATIONAL, MAISONS- Manufacturer: GLAXO SMITHKLINE PHARMACEUTICALS,
ALFORT-CEDEX, FRANCE ALFORT-CEDEX, FRANCE WORTHING, SUSSEX, UK
AVENTIS PHARMA LE TRAIT, LE AVENTIS PHARMA LE TRAIT, LE TRAIT,
TRAIT, FRANCE FRANCE
Packer: AVENTIS INTERNATIONAL, MAISONS- Packer: AVENTIS INTERNATIONAL, MAISONS- Packer GLAXO SMITHKLINE PHARMACEUTICALS,
AVENTIS PHARMA LE TRAIT, LE AVENTIS PHARMA LE TRAIT, LE TRAIT,
TRAIT, FRANCE FRANCE
WINTHROP PHARMACEUTICALS, WINTHROP PHARMACEUTICALS, WALTLOO,
WALTLOO, PRETORIA, RSA PRETORIA, RSA
Laboratory: FPRC : AVENTIS INTERNATIONAL, MAISONS- Laboratory: FPRC: AVENTIS INTERNATIONAL, MAISONS- Laboratory: FPRC GLAXO SMITHKLINE PHARMACEUTICALS,
AVENTIS PHARMA LE TRAIT, LE AVENTIS PHARMA LE TRAIT, LE TRAIT, GENERICS (UK) LTD, STATION CLOSE,
TRAIT, FRANCE FRANCE HERTFORDSHIRE, UK
GERARD LABORATORIES, DUBLIN, IRELAND
SABS COMMERCIAL (PTY) LTD
PHARMACEUTICAL CHEMISTRY DEPARTMENT;
GROENKLOOF, PRETORIA, RSA
MERCK PHARMACEUTICAL MANUFACTURING,
WADEVILLE, GERMISTON
RESEARCH INSTITUTE FOR INDUSTRIAL

PHARMACY, NORTH-WEST UNIVERSITY,
POTCHEFSTROOM, RSA
FPRC/FPRR WINTHROP PHARMACEUTICALS FPRC/FPRR WINTHROP PHARMACEUTICALS WALTLOO, FPRR: XIXIA PHARMACEUTICALS, MODDERFONTEIN,
WALTLOO, PRETORIA PRETORIA JOHANNESBURG, RSA
FPRR: SANOFI-AVENTIS S.A., MIDRAND, RSA FPRR: SANOFI-AVENTIS S.A., MIDRAND, RSA Shelf-life: 24 months
Shelf-life: 24 months Shelf-life: 24 months Date of registration: 26 OCTOBER 2012
Date of registration: 26 OCTOBER 2012 Date of registration: 26 OCTOBER 2012
No. 36136
9
10
MRF 15 MRF15 vIRF 15
Registration number: 42/20.1.2/0213 Registration number: 42/20.1.1/0251 42/20.1.1/0252

Registration number:
Name of medicine: CLAMGEN IV 1,2 Name of medicine: LITHA PIPERACILLIN CO 2/0,250 Name of medicine: LITHA PIPERACILLIN CO 3/0,375
No. 36136
Dosage form: INJECTION Dosage form: POWDER FOR INJECTION Dosage form: POWDER FOR INJECTION
Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS: EACH VIAL CONTAINS:
Active ingredients:
AMOXICILLIN SODIUM EQUIVALENT PIPERACILLIN SODIUM EQUIVALENT TO PIPERACILLIN SODIUM EQUIVALENT
TO AMOXICILLIN 1 000,0 mg PIPERACILLIN 2,0 g TO
POTASSIUM CLAVULANATE TAZOBACTAM SODIUM EQUIVALENT TO PIPERACILLIN 3,0 g
EQUIVALENT TO TAZOBACTAM 0,250 g TAZOBACTAM SODIUM EQUIVALENT
CLAVULANIC ACID 200,0 mg TO
TAZOBACTAM 0,375 g
Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8
Applicant: XIXIA PHARMACEUTICALS (PTY) LTD Applicant LITHA PHARMA (PTY) LTD LITHA PHARMA (PTY) LTD
Applicant:
Manufacturer: GLAXO SMITHKLINE Manufacturer: MITIM S.r.L, BRESCIA, ITALY Manufacturer: MITIM S.r.L, BRESCIA, ITALY
PHARMACEUTICALS, WORTHING,
SUSSEX, UK
Packer: GLAXO SMITHKLINE Packer: MITIM S.r.L, BRESCIA, ITALY Packer: MITIM S.r.L, BRESCIA, ITALY
PHARMACEUTICALS, WORTHING,
SUSSEX, UK
Laboratory: FPRC: GLAXO SMITHKLINE Laboratory: FPRC: MITIM S.r.L, BRESCIA, ITALY MITIM S.r.L, BRESCIA, ITALY
Laboratory::FPRC
PHARMACEUTICALS, WORTHING, CONSULTING CHEMICAL LABORATORIES (PTY) CONSULTING CHEMICAL
SUSSEX, UK LTD, ATLASVILLE, BOKSBURG, RSA LABORATORIES (PTY) LTD,
GENERICS (UK) LTD, STATION SEDEKAGRICHEM, SILVERTONDALE, PRETORIA, ATLASVILLE, BOKSBURG, RSA
CLOSE, HERTFORDSHIRE, UK RSA SEDEKAGRICHEM, SILVERTONDALE,
GERARD LABORATORIES, DUBLIN, PRETORIA, RSA
IRELAND
PHARMACEUTICAL CHEMISTRY
DEPARTMENT; GROENKLOOF,
PRETORIA, RSA
MERCK PHARMACEUTICAL
MANUFACTURING, WADEVILLE,
GERMISTON
RESEARCH INSTITUTE FOR
INDUSTRIAL PHARMACY, NORTH-
WEST UNIVERSITY,
POTCHEFSTROOM, RSA
FPRR: XIXIA PHARMACEUTICALS, FPRR: LITHA PHARMA (PTY) LTD, MIDRAND, RSA FPRR LITHA PHARMA (PTY) LTD, MIDRAND,
MODDERFONTEIN, RSA
JOHANNESBURG, RSA
Shelf-life: 24 months Shelf-life: 24 months (Provisional) 24 months (Provisional)

Shelf-life:
Registration number: 42/20.1.1/0253 Registration number: 42/3.1/0831 Registration 42/26/0961
number:
Name of medicine: LITHA PIPERACILLIN CO 4/0,5 Name of medicine: VOLTAREN ACTI-GO SOFT GEL Name of medicine: TEMODAL 140 mg
CAPSULE
Dosage form: POWDER FOR INJECTION Dosage form: SOFT GEL CAPSULE Dosage form: CAPSULE
Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH CAPSULE
PIPERACILLIN SODIUM DICLOFENAC POTASSIUM 12,5 mg CONTAINS:
EQUIVALENT TO
TEMOZOLOMIDE 140,0 mg
PIPERACILLIN 4,0 g
TAZOBACTAM SODIUM
EQUIVALENT TO
TAZOBACTAM 0,5 g
Conditions of 1, 2, 3, 4, 5, 6, 7, 8 Conditions of Conditions of
1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7, 8
registration: registration: registration:
Applicant: LITHA PHARMA (PTY) LTD Applicant: NOVARTIS SA (PTY) LTD Applicant: SCHERING-PLOUGH (PTY)
LTD
Manufacturer: MITIM S.r.L, BRESCIA, ITALY Manufacturer: RP SCHERER GmbH & Co. KG, Manufacturer: ORION CORPORATION,
EBERBACH/BADEN, GERMANY TURKU, FINLAND
Packer: MITIM S.r.L, BRESCIA, ITALY Packer: CARDINAL HEALTH GERMANY 405 Packer: ORION CORPORATION,
GmbH, STEINBEISSTRASSE, TURKU, FINLAND
SCHORNDORF, GERMANY SCHERING-PLOUGH LABO
NM., HEIST-OP-DEN-
BERG, BELGIUM
Laboratory: FPRC: MITIM S.r.L, BRESCIA, ITALY Laboratory: FPRC: RP SCHERER GmbH & Co. KG, Laboratory: FPRC: ORION CORPORATION,
CONSULTING CHEMICAL EBERBACH/BADEN, GERMANY TURKU, FINLAND
LABORATORIES (PTY) LTD, SANDOZ SA (PTY) LTD, SPARTAN, SCHERING-PLOUGH LABO
ATLASVILLE, BOKSBURG, RSA KEMPTON PARK, RSA N.V., HEIST-OP-DEN-
SEDEK AGRICHEM, TECHNIKON LABORATORIES, BERG, BELGIUM
SILVERTONDALE, PRETORIA, ROBERTVILLE, FLORIDA, RSA SGS LAB SIMON SA,
RSA WAVRE, BELGIUM
CONSULTING CHEMICAL
LABORATORIES,
ATLASVILLE, BOKSBURG,
RSA
KHULULEKANI
LABORATORY SERVICES,
COVENTRY PARK,
MIDRAND, RSA
FPRR: LITHA PHARMA (PTY) LTD, FPRR: FPRR:
NOVARTIS SA (PTY) LTD, SCHERING-PLOUGH,
MIDRAND, RSA SPARTAN, KEMPTON PARK, RSA WOODMEAD, SANDTON,
RSA
Shelf-life: 24 months (Provisional) Shelf-life: 24 months Shelf-life: 24 months (Provisional)
Date of registration: 26 OCTOBER 2012 Date of registration: 26 OCTOBER 2012 Date of 26 OCTOBER 2012
No. 36136
registration:
11
12
MRF 15 MRF15 F 15
No. 36136
Registration number: 42/26/0962 Registration number: 43/5.4.1/0133 Registration number: 43/5.4.1/0134

Name of medicine: TEMODAL 180 mg Name of medicine: GULF PRAMIPEXOLE 0,25 mg Name of medicine: GULF PRAMIPEXOLE 0,125 mg
Dosage form: CAPSULE Dosage form: TABLET Dosage form: TABLET
Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS:
TEMOZOLOMIDE 180,0 mg Pramipexole dihydrochloride Pramipexole dihydrochloride monohydrate
monohydrate 0,25 mg 0,125 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of 1, 2, 3, 4, 5, 6, 7, 8
registration:
Applicant: SCHERING-PLOUGH (PTY) LTD Applicant: GULF DRUG COMPANY (PTY) LTD Applicant: GULF DRUG COMPANY (PTY) LTD
Manufacturer: ORION CORPORATION, TURKU, Manufacturer ALEMBIC LIMITED (FORMULATION Manufacturer: ALEMBIC LIMITED (FORMULATION DIVISION),
FINLAND DIVISION), TAL-HALOL, DISTRICT TAL-HALOL, DISTRICT PANCHMAHALS,
PANCHMAHALS, GUJARAT, INDIA GUJARAT, INDIA
Packer: ORION CORPORATION, TURKU, Packer: ALEMBIC LIMITED (FORMULATION Packer: ALEMBIC LIMITED (FORMULATION DIVISION),
SCHERING-PLOUGH LABO NM., PANCHMAHALS, GUJARAT, INDIA GUJARAT, INDIA
HEIST-OP-DEN-BERG, BELGIUM
Laboratory: FPRC: ORION CORPORATION, TURKU, Laboratory: FPRC: ALEMBIC LIMITED (FORMULATION Laboratory: FPRC: ALEMBIC LIMITED (FORMULATION DIVISION),
SCHERING-PLOUGH LABO N.V., PANCHMAHALS, GUJARAT, INDIA GUJARAT, INDIA
HEIST-OP-DEN-BERG, BELGIUM SABS COMMERCIAL (PTY) LTD SABS COMMERCIAL (PTY) LTD
SGS LAB SIMON SA, WAVRE, PHARMACEUTICAL CHEMISTRY PHARMACEUTICAL CHEMISTRY DEPARTMENT
BELGIUM DEPARTMENT GROENKLOOF, GROENKLOOF, PRETORIA, RSA
CONSULTING CHEMICAL PRETORIA, RSA M&L LABORATORY SERCICES (PTY) LTD,
LABORATORIES, ATLASVILLE, M&L LABORATORY SERCICES (PTY) LIMBRO BUSINESS PARK, SANDTON, RSA
BOKSBURG, RSA LTD, LIMBRO BUSINESS PARK, CONSULTING CHEMICAL LABORATORIES (PTY)
KHULULEKANI LABORATORY SANDTON, RSA LTD, ATLASVILLE, BOKSBURG, RSA
SERVICES, COVENTRY PARK, CONSULTING CHEMICAL INSTITUTE FOR PHARMACEUTICAL SERVICES,
MIDRAND, RSA LABORATORIES (PTY) LTD, SILVERTONDALE, PRETORIA, RSA
ATLASVILLE, BOKSBURG, RSA CONSULTING MICROBIOLOGICAL PHARMA-Q
INSTITUTE FOR PHARMACEUTICAL (PTY) LTD, INDUSTRIA WEST,
SERVICES, SILVERTONDALE, JOHANNESBURG, RSA
PRETORIA, RSA
CONSULTING MICROBIOLOGICAL
PHARMA -Q (PTY) LTD, INDUSTRIA
WEST, JOHANNESBURG, RSA

FPRR: SCHERING-PLOUGH, FPRR: GULF DRUG COMPANY (PTY) LTD, FPRR: GULF DRUG COMPANY (PTY) LTD, MOUNT
WOODMEAD, SANDTON, RSA MOUNT EDGECOMBE, RSA EDGECOMBE, RSA
Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional)
MRF 15 MRF15 F 15
Registration number: 43/5.4.110135 Registration number: Registration number

43/2.2/0171 43/2.2/0172
Name of medicine: GULF PRAMIPEXOLE 1,0 mg Name of medicine: Name of medicine:
MIDAZOLAM B.BRAUN MIDAZOLAM B.BRAUN 5 mg/ml
1 mg/ml
Dosage form: TABLET Dosage form: SOLUTION FOR INJECTION Dosage form: SOLUTION FOR INJECTION
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH AMPOULE Active ingredients: EACH AMPOULE CONTAINS:
Pramipexole dihydrochloride monohydrate
1,0 mg CONTAINS: MIDAZOLAM MIDAZOLAM 5,0 mg
1,0 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: Conditions of registration:
1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7
Applicant: GULF DRUG COMPANY (PTY) LTD Applicant: B BRAUN MEDICAL (PTY) Applicant: B BRAUN MEDICAL (PTY) LTD
LTD
Manufacturer: ALEMBIC LIMITED (FORMULATION Manufacturer. Manufacturer:
B. BRAUN MELSUNGEN B. BRAUN MELSUNGEN AG, BERLIN,
DIVISION), TAL-HALOL, DISTRICT
PANCHMAHALS, GUJARAT, INDIA AG, BERLIN, GERMANY GERMANY
B. BRAUN MEDICAL S.A., B. BRAUN MEDICAL S.A., JAEN,
JAEN, SPAIN SPAIN
Packer: ALEMBIC LIMITED (FORMULATION Packer: Packer:
B. BRAUN MELSUNGEN B. BRAUN MELSUNGEN AG, BERLIN,
B. BRAUN MEDICAL S.A., B. BRAUN MEDICAL S.A., JAEN,
JAEN, SPAIN SPAIN
Laboratory: FPRC ALEMBIC LIMITED (FORMULATION Laboratory: FPRC: B. BRAUN MELSUNGEN Laboratory: FPRC:
B. BRAUN MELSUNGEN AG, BERLIN,
SABS COMMERCIAL (PTY) LTD B. BRAUN MEDICAL S.A., B. BRAUN MEDICAL S.A., JAEN,
JAEN, SPAIN SPAIN
DEPARTMENT GROENKLOOF,
PRETORIA, RSA CONSULTING CHEMICAL CONSULTING CHEMICAL
M&L LABORATORY SERCICES (PTY) LTD, LABORATORIES, LABORATORIES, ATLASVILLE,
LIMBRO BUSINESS PARK, SANDTON,
RSA ATLASVILLE, BOKSBURG, BOKSBURG, RSA
CONSULTING CHEMICAL RSA M&L LABORATORY SERVICES,
LABORATORIES (PTY) LTD, ATLASVILLE, M&L LABORATORY LIMBRO BUSINESS PARK, SANDTON,
BOKSBURG, RSA
INSTITUTE FOR PHARMACEUTICAL
SERVICES, LIMBRO JOHANNESBURG, RSA
SERVICES, SILVERTONDALE, PRETORIA, BUSINESS PARK, PHARMA-Q (PTY) LTD, INDUSTRIA

RSA SANDTON, WEST, JOHANNESBURG, RSA
CONSULTING MICROBIOLOGICAL
PHARMA-Q (PTY) LTD, INDUSTRIA WEST,
JOHANNESBURG, RSA
JOHANNESBURG, RSA PHARMA-Q (PTY) LTD,
INDUSTRIA WEST,
JOHANNESBURG, RSA
FPRR: GULF DRUG COMPANY (PTY) LTD, FPRR: FPRR:
MOUNT EDGECOMBE, RSA
B BRAUN MEDICAL (PTY) B BRAUN MEDICAL (PTY) LTD,
LTD, HONEYDEW, HONEYDEW, GAUTENG, RSA
GAUTENG, RSA
Shelf-life: 24 months (Provisional) Shelf-life: Shelf-life:
24 months 24 months
Date of registration: 26 OCTOBER 2012 Date of registration: Date of registration:
No. 36136
13
14
MRF 15 MRF15 2,F 15
Registration number: 43/20.1.1/0190 Registration number: 43/20.1.1/0191 Registration number: 43/26/0246

No. 36136
Name of medicine: DRL LEVOFLOXACIN 250 Name of medicine: DRL LEVOFLOXACIN 500 Name of medicine: GENEXOL 300 mg
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH CONTAINS: Active ingredients: EACH VIAL CONTAINS:
Levofloxacin 250,0 mg Levofloxacin 500,0 mg PACLITAXEL 300,0 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8
Applicant: DR REDDY'S LABORATORIES (PTY) LTD Applicant: DR REDDY'S LABORATORIES (PTY) LTD Applicant: PHARMACORP cc
Manufacturer: DR REDDY'S LABORATORIES LIMITED Manufacturer: DR REDDY'S LABORATORIES LIMITED Manufacturer: INTAS PHARMACEUTICALS LTD, MATODA,
(GENERICS), QUTHUBULLAPUR (GENERICS), QUTHUBULLAPUR MANDAL, TALUKA-SANAND, AHMEDABAD, INDIA
MANDAL, RANGA REDDY DISTRICT, RANGA REDDY DISTRICT, ANDHRA
ANDHRA PRADESH, INDIA PRADESH, INDIA
DR REDDY'S LABORATORIES LIMITED DR REDDY'S LABORATORIES LIMITED
(FTO/FM-II), QUTHUBULLAPUR (FTO/FM-II), QUTHUBULLAPUR MANDAL,
Packer: DR REDDY'S LABORATORIES LIMITED Packer: DR REDDY'S LABORATORIES LIMITED Packer: INTAS PHARMACEUTICALS LTD, MATODA,
DRA PHARMACEUTICALS, IRENE, DRA PHARMACEUTICALS, IRENE,
CENTURION, RSA CENTURION, RSA
Laboratory: FPRC: DR REDDY'S LABORATORIES LIMITED Laboratory: FPRC: DR REDDY'S LABORATORIES LIMITED Laboratory: FPRC: INTAS PHARMACEUTICALS LTD, MATODA,
MANDAL, RANGA REDDY DISTRICT, RANGA REDDY DISTRICT, ANDHRA COLUMBIA PHARMACEUTICALS, BARDENE,
ANDHRA PRADESH, INDIA PRADESH, INDIA BOKSBURG, RSA
INSTITUTE FOR PHARMACEUTICAL INSTITUTE FOR PHARMACEUTICAL
SERVICES, SILVERTONDALE, SERVICES, SILVERTONDALE, PRETORIA,
PRETORIA, RSA RSA

RESEARCH INSTITUTE FOR RESEARCH INSTITUTE FOR INDUSTRIAL
INDUSTRIAL PHARMACY, NORTH-WEST PHARMACY, NORTH-WEST UNIVERSITY,
UNIVERSITY, POTCHEFSTROOM, RSA POTCHEFSTROOM, RSA
FPRR: DR REDDY'S LABORATORIES (PTY) FPRR: DR REDDY'S LABORATORIES (PTY) LTD, FPRR: PHARMACORP cc, ARCADIA, PRETORIA, RSA
LTD, SANDTON, JOHANNESBURG, RSA SANDTON, JOHANNESBURG, RSA
MRF 15 MRF15 MRF 15
Registration number: 43/7.1.3/0301 Registration number: 43/7.1.3/0302 Registration number: 43/7.1.3/0303

Name of medicine: VALANT 40 Name of medicine: VALANT 80 Name of medicine: VALANT 160
Dosage form: TABLET Dosage form: TABLET Dosage form: TABLET
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS:
VALSARTAN 40,0 mg VALSARTAN 80,0 mg VALSARTAN 160,0 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7
Applicant: PHARMAPLAN (PTY) LTD Applicant PHARMAPLAN (PTY) LTD Applicant: PHARMAPLAN (PTY) LTD
Manufacturer: PHARMASCIENCE INC, Manufacturer: PHARMASCIENCE INC, Manufacturer: PHARMASCIENCE INC,
ROYALMOUNT AVENUE, ROYALMOUNT AVENUE, ROYALMOUNT, AVENUE,
MONTREAL, QUEBEC, CANADA MONTREAL, QUEBEC, CANADA MONTREAL, QUEBEC, CANADA
Packer: PHARMASCIENCE INC, Packer: PHARMASCIENCE INC, Packer: PHARMASCIENCE INC,
ROYALMOUNT AVENUE, ROYALMOUNT AVENUE, ROYALMOUNT AVENUE,
PHARMASCIENCE INC, DE PHARMASCIENCE INC, DE PHARMASCIENCE INC, DE
L'ESPLANADE AVENUE, L'ESPLANADE AVENUE, L'ESPLANADE AVENUE,
ROPACK MIRABEAU, MONTREAL, ROPACK MIRABEAU, MONTREAL, ROPACK MIRABEAU,
QUEBEC, CANADA QUEBEC, CANADA MONTREAL, QUEBEC, CANADA
DIVPHARM MANUFACTURING AND DIVPHARM MANUFACTURING AND DIVPHARM MANUFACTURING
PACKAGING (PTY) LTD, PACKAGING (PTY) LTD, AND PACKAGING (PTY) LTD,
LONGDALE, INDUSTRIA, LONGDALE, INDUSTRIA, LONGDALE, INDUSTRIA,
JOHANNESBURG, RSA JOHANNESBURG, RSA JOHANNESBURG, RSA
Laboratory: FPRC: PHARMASCIENCE INC, Laboratory: FPRC: PHARMASCIENCE INC, Laboratory: FPRC PHARMASCIENCE INC,
ROYALMOUNT AVENUE, ROYALMOUNT AVENUE, ROYALMOUNT AVENUE,
PHARMASCIENCE INC, DE PHARMASCIENCE INC, DE PHARMASCIENCE INC, DE
L'ESPLANADE AVENUE, L'ESPLANADE AVENUE, L'ESPLANADE AVENUE,
CONSULTING CHEMICAL CONSULTING CHEMICAL CONSULTING CHEMICAL
LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD,
LABORATORIES (PTY) LTD,

ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, RSA
FPRR: PHARMAPLAN (PTY) LTD, FPRR: PHARMAPLAN (PTY) LTD, FPRR: PHARMAPLAN (PTY) LTD,
MIDRAND, RSA MIDRAND, RSA MIDRAND, RSA

No. 36136
15
MRF 15 MRF 15 16
Name of medicine: PSYQUET 25 Name of medicine: SANDOZ QUETIAPINE 25 Name of medicine: SIBELIUM T 5 mg
No. 36136
Quetiapine hemifumarate Quetiapine hemifumarate FLUNARIZINE
equivalent to Quetiapine equivalent to Quetiapine HYDROCHLORIDE
25,0 mg 25,0 mg EQUIVALENT TO
FLUNARIZINE 5,0 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: Conditions of
1, 2, 3, 4, 5, 6, 7,8 1, 2, 3, 4, 5, 6, 7
registration:
Applicant: SANDOZ. SA (PTY) LTD Applicant: SANDOZ SA (PTY) LTD Applicant: JANSSEN PHARMACEUTICA
(PTY) LTD
Manufacturer: SANDOZ ILAC SANAYI VE Manufacturer: SANDOZ ILAC SANAYI VE Manufacturer:
JANSSEN-CILAG S.P.A, LATINA,
TICARET A.S, GEBZE- TICARET A.S, GEBZE- ITALY
KOCAELI, TURKEY KOCAELI, TURKEY
Packer: SANDOZ ILAC SANAYI VE Packer: SANDOZ ILAC SANAYI VE Packer:
JANSSEN-CILAG S.P.A, LATINA,
KOCAELI, TURKEY KOCAELI, TURKEY SPECPHARM HOLDINGS (PTY)
TECHNIKON TECHNIKON LTD, HALFWAY HOUSE,
LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD, MIDRAND, RSA
ROBERTVILLE, FLORIDA, ROBERTVILLE, FLORIDA,
RSA RSA
SANDOZ SA, SPARTAN, SANDOZ SA, SPARTAN,
Laboratory: FPRC: SANDOZ ILAC SANAYI VE Laboratory: FPRC: SANDOZ ILAC SANAYI VE Laboratory: FPRC: JANSSEN-CILAG S.P.A, LATINA,
KOCAELI, TURKEY KOCAELI, TURKEY SPECPHARM HOLDINGS (PTY)
CONSULTING CHEMICAL CONSULTING CHEMICAL LTD, HALFWAY HOUSE,
LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD, MIDRAND, RSA
ATLASVILLE, BOKSBURG, ATLASVILLE, BOKSBURG,
RSA RSA
SABS COMMERCIAL (PTY) SABS COMMERCIAL (PTY)

LTD PHARMACEUTICAL LTD PHARMACEUTICAL
CHEMISTRY DEPARTMENT CHEMISTRY DEPARTMENT
GROENKLOOF, PRETORIA, GROENKLOOF, PRETORIA,
RSA RSA
FPRC/FPRR: SANDOZ SA (PTY) LTD, FPRC/FPRR: FPRR:
SANDOZ SA (PTY) LTD, JANSSEN PHARMACEUTICA
SPARTAN, KEMPTON PARK, SPARTAN, KEMPTON (PTY) LTD, WOODMEAD,
RSA PARK, RSA JOHANNESBURG, RSA
24 months (Provisional) 24 months
MRF 15 MRF15 MRF 15

Name of medicine: ACCORD ROPINIROLE Name of medicine: ACCORD ROPINIROLE Name of medicine: ACCORD ROPINIROLE 1 mg
0,5 mg 0,25 mg
ROPINIROLE HCI 0,5 mg ROPINIROLE HCI 0,25 mg ROPINIROLE HCI 1,0 mg
Applicant: ACCORD HEALTHCARE Applicant: ACCORD HEALTHCARE Applicant: ACCORD HEALTHCARE (PTY) LTD
(PTY) LTD (PTY) LTD
Manufacturer: INTAS PHARMACEUTICALS Manufacturer: INTAS Manufacturer: INTAS PHARMACEUTICALS
LIMITED, VILLAGE MATODA, PHARMACEUTICALS LIMITED, VILLAGE MATODA,
TALUKA, AHMEDABAD, LIMITED, VILLAGE TALUKA, AHMEDABAD, GUJARAT,
GUJARAT, INDIA MATODA, TALUKA, INDIA
AHMEDABAD, GUJARAT,
INDIA
Packer: INTAS PHARMACEUTICALS Packer: INTAS Packer: INTAS PHARMACEUTICALS
AHMEDABAD, GUJARAT,
INDIA
Laboratory: FPRC: INTAS PHARMACEUTICALS Laboratory: FPRC: INTAS Laboratory: FPRC INTAS PHARMACEUTICALS
CONSULTING CHEMICAL AHMEDABAD, GUJARAT, CONSULTING CHEMICAL
LABORATORIES (PTY) LTD, INDIA LABORATORIES (PTY) LTD,
ATLASVILLE, BOKSBURG, CONSULTING CHEMICAL ATLASVILLE, BOKSBURG, RSA

RSA LABORATORIES (PTY)
LTD, ATLASVILLE,
BOKSBURG, RSA
FPRR: ACCORD HEALTHCARE FPRR: ACCORD HEALTHCARE FPRR: ACCORD HEALTHCARE (PTY) LTD,
(PTY) LTD, RIVONIA, (PTY) LTD, RIVONIA, RIVONIA, GAUTENG, RSA
GAUTENG, RSA GAUTENG, RSA
No. 36136
17
18
MRF 15 MRF15 MRF 15
Registration number: 43/5.4.1/0508 Registration number: 43/5.4.1/0509 Registration number: 43/26/0540
Name of medicine: ACCORD ROPINIROLE 2 mg Name of medicine: Name of medicine:
ACCORD ROPINIROLE 5 mg TEMODAL 100 mg/ml
POWDER FOR INJECTION
No. 36136
Dosage form: TABLET Dosage form: TABLET Dosage form: POWDER FOR INJECTION
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH VIAL CONTAINS:
ROPINIROLE HCI 2,0 mg ROPINIROLE HCI 5,0 mg TEMOZOLOMIDE 100,0 mg
1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7
Applicant: ACCORD HEALTHCARE (PTY) Applicant: ACCORD HEALTHCARE (PTY) Applicant: SCHERING-PLOUGH (PTY)
LTD LTD LTD
Manufacturer: INTAS PHARMACEUTICALS Manufacturer. Manufacturer.
INTAS PHARMACEUTICALS BAXTER ONCOLOGY
LIMITED, VILLAGE MATODA, LIMITED, VILLAGE MATODA, GmbH, HALLENVESTFALEN,
TALUKA, AHMEDABAD, TALUKA, AHMEDABAD, GERMANY
GUJARAT, INDIA GUJARAT, INDIA
Packer: INTAS PHARMACEUTICALS Packer: Packer:
INTAS PHARMACEUTICALS BAXTER ONCOLOGY
GUJARAT, INDIA GUJARAT, INDIA SCHERING-PLOUGH LABO
N.V., HEIST-OP-DEN-BERG,
BELGIUM
Laboratory: FPRC: INTAS PHARMACEUTICALS Laboratory: FPRC: INTAS PHARMACEUTICALS Laboratory: FPRC BAXTER ONCOLOGY
GUJARAT, INDIA GUJARAT, INDIA SCHERING-PLOUGH LABO
CONSULTING CHEMICAL CONSULTING CHEMICAL N.V., HEIST-OP-DEN-BERG,
LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD, BELGIUM
ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, CONSULTING CHEMICAL
RSA LABORATORIES,
ATLASVILLE, BOKSBURG,
RSA
KHULULEKANI
LABORATORY SERVICES,
COVENTRY PARK,
MIDRAND, RSA
FPRR: ACCORD HEALTHCARE (PTY) FPRR: FPRR:
ACCORD HEALTHCARE (PTY) SCHERING-PLOUGH,
LTD, RIVONIA, GAUTENG, RSA LTD, RIVONIA, GAUTENG, RSA WOODMEAD, SANDTON,
RSA
Shelf-life: 36 months Shelf-life: Shelf-life:
36 months 36 months
MRF 15 MRF15 MRF 15
Registration number: 43/18.3/0701 Registration number: 43/21.12/0726 Registration number: 43/2.6.5/0849
Name of medicine: SORBISTERIT POWDER FOR Name of medicine: LETOZ 2,5 TABLETS Name of medicine: PSYQUET 100
ORAL SUSPENSION
Dosage form: POWDER FOR ORAL Dosage form: TABLET Dosage form: TABLET
SUSPENSION
Active ingredients: EACH 1,0 g POWDER Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS:
CONTAINS: LETROZOLE 2,5 mg Quetiapine hemifumarate
CALCIUM POLYSTYRENE equivalent to Quetiapine 100,0 mg
SULPHONATE 7,59 - 9,49 g
Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8
Applicant: FRESENIUS KABI SA (PTY) LTD Applicant: ZYDUS HEALTHCARE SA (PTY) LTD Applicant: SANDOZ SA (PTY) LTD
Manufacturer: FRESENIUS MEDICAL CARE Manufacturer: ZYDUS CADILA HEALTHCARE Manufacturer: SANDOZ ILAC SANAYI VE
DEUTSCHLAND GmbH, ST. LIMITED, SANAND, AHMEDABAD, TICARET A.S, GEBZE-KOCAELI,
WENDEL, GERMANY INDIA TURKEY
Packer: FRESENIUS MEDICAL CARE Packer: ZYDUS CADILA HEALTHCARE Packer: SANDOZ ILAC SANAYI VE
TECHNIKON LABORATORIES
(PTY) LTD, ROBERTVILLE,
FLORIDA, RSA
SANDOZ SA, SPARTAN,
KEMPTON PARK, RSA
Laboratory: FPRC: FRESENIUS MEDICAL CARE Laboratory: FPRC: ZYDUS CADILA HEALTHCARE Laboratory: FPRC SANDOZ ILAC SANAYI VE
BODENE (PTY) LIMITED INSTITUTE FOR PHARMACEUTICAL CONSULTING CHEMICAL
TRADING AS INTRAMED, SERVICES, SILVERTONDALE, LABORATORIES (PTY) LTD,
KORSTEN, PORT ELIZABETH, PRETORIA, RSA ATLASVILLE, BOKSBURG, RSA
RSA INSTITUTE FOR INDUSTRIAL SABS COMMERCIAL (FTY) LTD
PHARMACY, NORTH-WEST PHARMACEUTICAL CHEMISTRY

UNIVERSITY, POTCHEFSTROOM, DEPARTMENT GROENKLOOF,
RSA PRETORIA, RSA
FPRR: FRESENIUS KABI SA (PTY) LTD, FPRR: ZYDUS HEALTHCARE SA (PTY) FPRC/FPRR: SANDOZ SA (PTY) LTD,
MIDRAND, RSA LTD, POTCHEFSTROOM, RSA SPARTAN, KEMPTON PARK, RSA
Shelf-life: 24 months Shelf-life: 36 months Shelf-life: 24 months (Provisional)

0
No. 36136
19
20
MRF 15 MRF15 IF 15
No. 36136
Name of medicine: PSYQUET 200 Name of medicine: PSYQUET 300 Name of medicine: SANDOZ QUETIAPINE 100
Quetiapine hemifumarate equivalent Quetiapine hemifumarate equivalent Quetiapine hemifumarate
to Quetiapine 200,0 mg to Quetiapine 300,0 mg equivalent to Quetiapine
100,0 mg
2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7, 8
Applicant: SANDOZ SA (PTY) LTD Applicant: SANDOZ SA (PTY) LTD Applicant: SANDOZ SA (PTY) LTD
Manufacturer. SANDOZ ILAC SANAYI VE Manufacturer: SANDOZ ILAC SANAYI VE TICARET Manufacturer: SANDOZ ILAC SANAYI VE
TICARET AS, GEBZE-KOCAELI, AS, GEBZE-KOCAELI, TURKEY TICARET A.S, GEBZE-KOCAELI,
TURKEY TURKEY
Packer: SANDOZ ILAC SANAYI VE Packer: SANDOZ ILAC SANAYI VE TICARET Packer: SANDOZ ILAC SANAYI VE
TICARET A.S, GEBZE- KOCAELI, A.S, GEBZE-KOCAELI, TURKEY TICARET A.S, GEBZE-KOCAELI,
TURKEY TECHNIKON LABORATORIES TURKEY
TECHNIKON LABORATORIES LTD, ROBERTVILLE, TECHNIKON LABORATORIES
(PTY) LTD, ROBERTVILLE, RSA (PTY) LTD, ROBERTVILLE,
FLORIDA, RSA SANDOZ SA, SPARTAN, KEMPTON FLORIDA, RSA
SANDOZ SA, SPARTAN, RSA SANDOZ SA, SPARTAN,
Laboratory: FPRC: SANDOZ ILAC SANAYI VE Laboratory: FPRC: SANDOZ ILAC SANAYI VE TICARET Laboratory: FPRC SANDOZ ILAC SANAYI VE
TICARET AS, GEBZE-KOCAELI, AS, GEBZE-KOCAELI, TURKEY TICARET AS, GEBZE-KOCAELI,
TURKEY CONSULTING CHEMICAL TURKEY
CONSULTING CHEMICAL (PTY) LTD, CONSULTING CHEMICAL
LABORATORIES (PTY) LTD, ATLASVILLE, BOKSBURG, RSA LABORATORIES (PTY) LTD,
ATLASVILLE, BOKSBURG, RSA COMMERCIAL (PTY) LTD ATLASVILLE, BOKSBURG, RSA
SABS COMMERCIAL (PTY) LTD CHEMISTRY SABS COMMERCIAL (PTY) LTD
PHARMACEUTICAL CHEMISTRY GROENKLOOF, PHARMACEUTICAL
DEPARTMENT GROENKLOOF, RSA CHEMISTRY DEPARTMENT
PRETORIA, RSA GROENKLOOF, PRETORIA,
RSA
FPRC/FPRR: SANDOZ SA (PTY) LTD, FPRC/FPRR: FPRC/FPRR:
SANDOZ SA (PTY) LTD, SPARTAN, SANDOZ SA (PTY) LTD,
SPARTAN, KEMPTON PARK, RSA PARK, RSA SPARTAN, KEMPTON PARK,
RSA

MRF 15 MRF15 MRF 15
Registration number: 43/2.6.5/0853 Registration number: 43/2.6.5/0854 Registration number: 43/21.3/0869

Name of medicine: SANDOZ QUETIAPINE 200 Name of medicine: SANDOZ QUETIAPINE 300 Name of medicine: THYROTROPIN ALFA GENZYME
0,9 mg/ml
Dosage form: TABLET Dosage form: TABLET Dosage form: POWDER FOR SOLUTION FOR
INJECTION
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH 1,0 ml CONTAINS:
Quetiapine hemifumarate equivalent to Quetiapine hemifumarate equivalent to THYROTROPIN ALFA 0,9 mg
Quetiapine 200,0 mg Quetiapine 300,0 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of 1, 2, 3, 4, 5, 6, 7
registration:
Applicant: SANDOZ SA (PTY) LTD Applicant: SANDOZ SA (PTY) LTD Applicant: GENZYME BIOPHARMACEUTICALS SA
(PTY)
Manufacturer: SANDOZ ILAC SANAYI VE TICARET Manufacturer: SANDOZ ILAC SANAYI VE TICARET Manufacturer: GENZYME CORPORATION, ALLSTON,
A.S, GEBZE-KOCAELI, TURKEY A.S, GEBZE-KOCAELI, TURKEY MASSACHUSETTS, USA
Packer: SANDOZ ILAC SANAYI VE TICARET Packer: SANDOZ ILAC SANAYI VE TICARET Packer: GENZYME CORPORATION, ALLSTON,
TECHNIKON LABORATORIES (PTY) TECHNIKON LABORATORIES (PTY)
LTD, ROBERTVILLE, FLORIDA, RSA LTD, ROBERTVILLE, FLORIDA, RSA
SANDOZ SA, SPARTAN, KEMPTON SANDOZ SA, SPARTAN, KEMPTON
PARK, RSA PARK, RSA
Laboratory: FPRC: SANDOZ ILAC SANAYI VE TICARET Laboratory: FPRC: SANDOZ ILAC SANAYI VE TICARET Laboratory: FPRC GENZYME CORPORATION, ALLSTON,
CONSULTING CHEMICAL CONSULTING CHEMICAL GENZYME CORPORATION, 45 NEW
LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD, YORK AVENUE, FRAMINGHAM,
ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, RSA MASSACHUSETTS, USA
SABS COMMERCIAL (PTY) LTD SABS COMMERCIAL (PTY) LTD GENZYME CORPORATION, 76 NEW
PHARMACEUTICAL CHEMISTRY PHARMACEUTICAL CHEMISTRY YORK AVENUE, FRAMINGHAM,
DEPARTMENT GROENKLOOF, DEPARTMENT GROENKLOOF, MASSACHUSETTS, USA
PRETORIA, RSA PRETORIA, RSA CONSULTING CHEMICAL
LABORATORIES, ATLASVILLE,
BOKSBURG, RSA
FPRC/FPRR: SANDOZ SA (PTY) LTD, SPARTAN, FPRC/FPRR: SANDOZ SA (PTY) LTD, SPARTAN, FPRR: GENZYME BIOPHARMACEUTICALS SA
KEMPTON PARK, RSA KEMPTON PARK, RSA (PTY) LTD, BRYANSTON, GAUTENG, RSA
Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Shelf-life: 36 months

In-use shelf life of 24 hours stored at
2 -8 °C
No. 36136
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22
MRF 15 MRF15 MRF 15

Name of medicine: WATSON RANITIDINE 150 Name of medicine: WATSON RANITIDINE 300 Name of medicine: PROPAN ATORVASTATIN
10 mg
No. 36136
RANITIDINE HCI EQUIVALENT TO RANITIDINE HCI EQUIVALENT TO ATORVASTATIN CALCIUM
RANITIDINE 150,0 mg RANITIDINE 300,0 mg EQUIVALENT TO
ATORVASTATIN 10,0 mg
registration:
Applicant: ARROW PHARMA SOUTH AFRICA Applicant ARROW PHARMA SOUTH AFRICA Applicant: ADCOCK INGRAM LIMITED
(PTY) LTD (PTY) LTD
Manufacturer: Rx MANUFACTURING INC, Manufacturer: Rx MANUFACTURING INC, Manufacturer: ACTAVIS hf,
MISSISSAUGA, ONTARIO, CANADA MISSISSAUGA, ONTARIO, CANADA HAFNARFJORDUR, ICELAND
ACTAVIS LTD, ZEJTUN,
MALTA
Packer. Rx MANUFACTURING INC, Packer: Rx MANUFACTURING INC, Packer: ACTAVIS hf,
TECHNIKON LABORATORIES (PTY) TECHNIKON LABORATORIES (PTY) ACTAVIS LTD, ZEJTUN,
LTD, ROBERTVILLE, FLORIDA, RSA LTD, ROBERTVILLE, FLORIDA, RSA MALTA
DIVPHARM MANUFACTURING AND DIVPHARM MANUFACTURING AND ADCOCK INGRAM
PACKAGING, LONGDALE, PACKAGING, LONGDALE, HEALTHCARE (PTY) LTD
INDUSTRIA, JOHANNESBURG, RSA INDUSTRIA, JOHANNESBURG, RSA (WADEVILLE), WADEVILLE,
GERMISTON, RSA
Laboratory: FPRC: RX MANUFACTURING INC, Laboratory: FPRC: RX MANUFACTURING INC, Laboratory: FPRC ACTAVIS hf,
TECHNIKON LABORATORIES (PTY) TECHNIKON LABORATORIES (PTY) ACTAVIS LTD, ZEJTUN,
LTD, ROBERTVILLE, FLORIDA, RSA LTD, ROBERTVILLE, FLORIDA, RSA MALTA
SEDEK AGRICHEM, KAMEELDRIFT- SEDEK AGRICHEM, KAMEELDRIFT-
EAST, PRETORIA, RSA EAST, PRETORIA, RSA
FPRR: ARROW PHARMA SOUTH AFRICA FPRR: ARROW PHARMA SOUTH AFRICA FPRC/FPRR: ADCOCK INGRAM
(PTY) LTD WOODMEAD, RSA (PTY) LTD WOODMEAD, RSA HEALTHCARE (PTY) LTD
( WADEVILLE), WADEVILLE,
GERMISTON, RSA
ADCOCK INGRAM LTD
(RESEARCH &
DEVELOPMENT), AEROTON,
JOHANNESBURG, RSA
Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) FPRR: ADCOCK INGRAM LTD,
ERAND GARDENS,
MIDRAND, RSA
Date of registration: 26 OCTOBER 2012 Date of registration: 26 OCTOBER 2012 Shelf-life: 24 months (Provisional)
Date of registration: 26 OCTOBER 2012

MRF 15 MRF15 MMRF 15
Registration number: 43/7.5/1108 Registration number: 43/7.5/1109 Registration number: 43/7.5/1110
Name of medicine: PROPAN ATORVASTATIN 20 mg Name of medicine: PROPAN ATORVASTATIN 40 mg Name of medicine: GOVAN ATORVASTATIN 10 mg
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM
EQUIVALENT TO ATORVASTATIN EQUIVALENT TO ATORVASTATIN EQUIVALENT TO
20,0 mg 40,0 mg ATORVASTATIN 10,0 mg
Applicant: ADCOCK INGRAM LIMITED Applicant: ADCOCK INGRAM LIMITED ADCOCK INGRAM LIMITED
Applicant:
Manufacturer: ACTAVIS hf, HAFNARFJORDUR, Manufacturer: ACTAVIS hf, HAFNARFJORDUR, Manufacturer: ACTAVIS hf, HAFNARFJORDUR,
ICELAND ICELAND ICELAND
ACTAVIS LTD, ZEJTUN, MALTA ACTAVIS LTD, ZEJTUN, MALTA ACTAVIS LTD, ZEJTUN, MALTA
Packer: ACTAVIS hf, HAFNARFJORDUR, Packer: ACTAVIS hf, HAFNARFJORDUR, Packer: ACTAVIS hf, HAFNARFJORDUR,
ADCOCK INGRAM HEALTHCARE ADCOCK INGRAM HEALTHCARE ADCOCK INGRAM
(PTY) LTD (WADEVILLE), (PTY) LTD (WADEVILLE), HEALTHCARE (PTY) LTD
WADEVILLE, GERMISTON, RSA WADEVILLE, GERMISTON, RSA (WADEVILLE), WADEVILLE,
GERMISTON, RSA
Laboratory: FPRC: ACTAVIS hf, HAFNARFJORDUR, Laboratory: ACTAVIS hf, HAFNARFJORDUR, Laboratory: FPRC ACTAVIS hf, HAFNARFJORDUR,
ICELAND FPRC: ICELAND ICELAND
FPRC/FPRR: ADCOCK INGRAM HEALTHCARE FPRC/ FPRR: ADCOCK INGRAM HEALTHCARE FPRC/FPRR: ADCOCK INGRAM
ADCOCK INGRAM LTD (RESEARCH ADCOCK INGRAM LTD GERMISTON, RSA
& DEVELOPMENT), AEROTON, (RESEARCH & DEVELOPMENT), ADCOCK INGRAM LTD

JOHANNESBURG, RSA AEROTON, JOHANNESBURG, RSA (RESEARCH &
JOHANNESBURG, RSA
FPRC: ADCOCK INGRAM LTD, ERAND FPRR: ADCOCK INGRAM LTD, ERAND FPRR: ADCOCK INGRAM LTD, ERAND
GARDENS, MIDRAND, RSA GARDENS, MIDRAND, RSA GARDENS, MIDRAND, RSA
No. 36136
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MRF 15 MRF15 MRF 15

No. 36136

Name of medicine: GOVAN ATORVASTATIN 20 mg Name of medicine: GOVAN ATORVASTATIN 40 mg Name of medicine: RESTAN ATORVASTATIN 10 mg
EQUIVALENT TO EQUIVALENT TO EQUIVALENT TO
ATORVASTATIN 20,0 mg ATORVASTATIN 40,0 mg ATORVASTATIN 10,0 mg
Applicant: ADCOCK INGRAM LIMITED Applicant: ADCOCK INGRAM LIMITED Applicant: ADCOCK INGRAM LIMITED
GERMISTON, RSA
Laboratory: FPRC: ACTAVIS hf, HAFNARFJORDUR, Laboratory: FPRC: ACTAVIS hf, HAFNARFJORDUR, Laboratory: FPRC ACTAVIS hf, HAFNARFJORDUR,
FPRC/FPRR: ADCOCK INGRAM HEALTHCARE FPRC/FPRR: ADCOCK INGRAM HEALTHCARE FPRC/FPRR: ADCOCK INGRAM
JOHANNESBURG, RSA
FPRR: ADCOCK INGRAM LTD, ERAND FPRR: ADCOCK INGRAM LTD, ERAND FPRR: ADCOCK INGRAM LTD, ERAND
300399—C
Name of medicine: RESTAN ATORVASTATIN 20 mg Name of medicine: RESTAN ATORVASTATIN 40 mg Name of medicine: ADCO ATORVASTATIN 10 mg
Applicant: ADCOCK INGRAM LIMITED Applicant: ADCOCK INGRAM LIMITED ADCOCK INGRAM LIMITED
Applicant:
(PTY) LTD ( WADEVILLE), (PTY) LTD (WADEVILLE), HEALTHCARE (PTY) LTD
GERMISTON, RSA
FPRC/FPRR: ADCOCK INGRAM HEALTHCARE FPRC/FPRR: ADCOCK INGRAM HEALTHCARE FPRC/FPRR: ADCOCK INGRAM

JOHANNESBURG, RSA
No. 36136
25
26
MRF 15 MRF15 F 15
No. 36136

Name of medicine: ADCO ATORVASTATIN 20 mg Name of medicine: ADCO ATORVASTATIN 40 mg Name of medicine: ALCHOLTIN 10 mg
1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7, 8
Applicant: ADCOCK INGRAM LIMITED Applicant: ADCOCK INGRAM LIMITED Applicant: ADCOCK INGRAM LIMITED
Manufacturer. ACTAVIS hf, HAFNARFJORDUR, Manufacturer: Manufacturer:
ACTAVIS hf, HAFNARFJORDUR, ACTAVIS hf, HAFNARFJORDUR,
Packer: ACTAVIS hf, HAFNARFJORDUR, Packer: Packer:
ACTAVIS hf, HAFNARFJORDUR, ACTAVIS hf, HAFNARFJORDUR,
GERMISTON, RSA
FPRC/FPRR: ADCOCK INGRAM HEALTHCARE FPRC/ FPRR: ADCOCK INGRAM HEALTHCARE FPRC/FPRR: ADCOCK INGRAM
(PTY) LTD ( WADEVILLE), (PTY) LTD ( WADEVILLE), HEALTHCARE (PTY) LTD
JOHANNESBURG, RSA
AEROTON, JOHANNESBURG, RSA (RESEARCH &

JOHANNESBURG, RSA
MRF 15 MRF15 MRF 15
Registration number: 43/7.5/1120 Registration number: 43/7.5/1121 Registration number: 44/13.4.1/0095

Name of medicine: ALCHOLTIN 20 mg Name of medicine: ALCHOLTIN 40 mg Name of medicine: MOMATE OINTMENT
Dosage form: TABLET Dosage form: TABLET Dosage form: OINTMENT
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH 1,0 g OINTMENT
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM CONTAINS:
EQUIVALENT TO EQUIVALENT TO
ATORVASTATIN
MOMETASONE FUROATE
20,0 mg ATORVASTATIN 40,0 mg
1,0 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7
Applicant: ADCOCK INGRAM LIMITED Applicant: ADCOCK INGRAM LIMITED Applicant: GLENMARK
PHARMACEUTICALS SA
(PTY) LTD
Manufacturer: ACTAVIS hf, HAFNARFJORDUR, Manufacturer: ACTAVIS hf, HAFNARFJORDUR, Manufacturer: GLENMARK
ICELAND ICELAND PHARMACEUTICALS
ACTAVIS LTD, ZEJTUN, MALTA ACTAVIS LTD, ZEJTUN, MALTA
LIMITED, DISTRICT SOLAN,
BADDI, HIMACHAL
PRADESH, INDIA
Packer: ACTAVIS hf, HAFNARFJORDUR, Packer: ACTAVIS hf, HAFNARFJORDUR, Packer: GLENMARK
ADCOCK INGRAM HEALTHCARE ADCOCK INGRAM HEALTHCARE LIMITED, DISTRICT SOLAN,
(PTY) LTD (WADEVILLE), BADDI, HIMACHAL
(PTY) LTD (WADEVILLE),
WADEVILLE, GERMISTON, RSA WADEVILLE, GERMISTON, RSA PRADESH, INDIA
Laboratory: FPRC: ACTAVIS hf, HAFNARFJORDUR, Laboratory: FPRC: ACTAVIS hf, HAFNARFJORDUR, Laboratory: FPRC GLENMARK
LIMITED, DISTRICT SOLAN,
BADDI, HIMACHAL
PRADESH, INDIA
SABS COMMERCIAL (PTY)
LTD PHARMACEUTICAL
CHEMISTRY DEPARTMENT
GROENKLOOF, PRETORIA,
RSA
FPRC/FPRR: ADCOCK INGRAM HEALTHCARE FPRC/FPRR: ADCOCK INGRAM HEALTHCARE FPRR: GLENMARK
(PTY) LTD (WADEVILLE), (PTY) LTD (WADEVILLE), PHARMACEUTICALS SA
WADEVILLE, GERMISTON, RSA WADEVILLE, GERMISTON, RSA
ADCOCK INGRAM LTD (RESEARCH ADCOCK INGRAM LTD (PTY) LTD, MIDRAND, RSA
& DEVELOPMENT), AEROTON, (RESEARCH & DEVELOPMENT),
JOHANNESBURG, RSA AEROTON, JOHANNESBURG, RSA
FPRR: ADCOCK INGRAM LTD, ERAND FPRR: ADCOCK INGRAM LTD, ERAND Shelf-life: 24 months
GARDENS, MIDRAND, RSA GARDENS, MIDRAND, RSA
Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 26 OCTOBER 2012
Date of registration: 26 OCTOBER 2012 Date of registration: 26 OCTOBER 2012
No. 36136
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MRF 15 MRF15 MRF 15
Registration number: 44/26/0098 Registration number: 44/26/0099 Registration number: 44/26/0100

No. 36136
Name of medicine: DOCETAXEL WINTHROP 20 Name of medicine: DOCETAXEL WINTHROP 80 Name of medicine: TAXOTERE 20 mg/1 ml RTU
mg/1 ml RTU mg/4 ml RTU
Dosage form: CONCENTRATE FOR Dosage form: CONCENTRATE FOR Dosage form: CONCENTRATE FOR SOLUTION
SOLUTION FOR INFUSION SOLUTION FOR INFUSION FOR INFUSION
Active ingredients: EACH 1,0 ml SOLUTION Active ingredients: EACH 4,0 ml SOLUTION Active ingredients: EACH 1,0 ml SOLUTION
CONTAINS: CONTAINS: CONTAINS:
DOCETAXEL TRIHYDRATE DOCETAXEL TRIHYDRATE DOCETAXEL TRIHYDRATE
DOCETAXEL 20,0 mg DOCETAXEL 80,0 mg DOCETAXEL 20,0 mg
registration:
Applicant: WINTHROP Applicant: WINTHROP Applicant: SANOFI-AVENTIS SA (PTY) LTD
PHARMACEUTICALS (PTY) LTD PHARMACEUTICALS (PTY)
LTD
Manufacturer: AVENTIS PHARMA Manufacturer: AVENTIS PHARMA Manufacturer: AVENTIS PHARMA DAGENHAM,
DAGENHAM, ESSEX, UNITED DAGENHAM, ESSEX, UNITED ESSEX, UNITED KINGDOM
KINGDOM KINGDOM
Packer: AVENTIS PHARMA Packer: AVENTIS PHARMA Packer: AVENTIS PHARMA DAGENHAM,
KINGDOM KINGDOM
Laboratory: FPRC: AVENTIS PHARMA Laboratory: FPRC: AVENTIS PHARMA Laboratory: FPRC AVENTIS PHARMA DAGENHAM,
KINGDOM KINGDOM M&L LABORATORY SERVICES,
M&L LABORATORY SERVICES, M&L LABORATORY LIMBRO BUSINESS PARK,
LIMBRO BUSINESS PARK, SERVICES, LIMBRO SANDTON, RSA
SANDTON, RSA BUSINESS PARK, SANDTON,
RSA
FPRR: WINTHROP FPRR: WINTHROP FPRR: SANOFI-AVENTIS SA (PTY) LTD,
PHARMACEUTICALS (PTY) PHARMACEUTICALS (PTY) MIDRAND, RSA
LTD, MIDRAND, RSA LTD, MIDRAND, RSA
MRF 15 MRF15 IF 15
Registration number: 44/26/0101 Registration number 44/24/0102 Registration number: 44/13.12/0109
Name of medicine: TAXOTERE 80 mg/4 ml RTU Name of medicine: Name of medicine:
PHOSPHOSORB 660 EPIDUO 0,1 %/2,5 %
Dosage form: CONCENTRATE FOR SOLUTION Dosage form: TABLET Dosage form: GEL
FOR INFUSION
Active ingredients: EACH 4,0 ml SOLUTION CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH 1,0 g GEL CONTAINS:
DOCETAXEL TRIHYDRATE CALCIUM ACETATE 660,0 mg ADAPALENE 1,0 mg
EQUIVALENT TO BENZOYL PEROXIDE
DOCETAXEL 80,0 mg 25,0 mg
1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7
Applicant: SANOFI-AVENTIS SA (PTY) LTD Applicant: FRESENIUS KABI SA (PTY) Applicant: GALDERMA
LTD LABORATORIES S.A. (PTY)
LTD
Manufacturer. AVENTIS PHARMA DAGENHAM, Manufacturer. Manufacturer
FRESENIUS MEDICAL CARE LABORATOIRES
ESSEX, UNITED KINGDOM DEUTSCHLAND GmbH, BAD GALDERMA, MONTDESIR,
HOMBURG, GERMANY ALBY-SUR-CHERAN,
FRANCE
Packer: AVENTIS PHARMA DAGENHAM, Packer: Packer:
HOMBURG, GERMANY ALBY-SUR-CHERAN,
FRANCE
Laboratory: FPRC: AVENTIS PHARMA DAGENHAM, Laboratory: FPRC: Laboratory: FPRC
M&L LABORATORY SERVICES, HOMBURG, GERMANY ALBY-SUR-CHERAN,
LIMBRO BUSINESS PARK, FRANCE
SANDTON, RSA TECHNIKON
ROBERTVILLE, FLORIDA,
RSA
FPRR: FPRR: FPRR:
SANOFI-AVENTIS SA (PTY) LTD, FRESENIUS KABI SA (PTY) GALDERMA
MIDRAND, RSA LTD, HALFWAY HOUSE, LABORATORIES S.A.,
MIDRAND, RSA BRYANSTON,
JOHANNESBURG
Shelf -life: 24 months (Provisional) Shelf-life: Shelf-life:
24 months 36 months
In-use shelf life of 5 weeks
stored at or below 25 °C
No. 36136
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MRF 15 MRF15 tF 15
No. 36136
Name of medicine: VOLTAREN ACTI-GO SOFT GEL Name of medicine: Name of medicine:
MOZOBIL DAMS 500 pg
CAPSULE 25 mg
Dosage form: SOFT GEL CAPSULE Dosage form: SOLUTION FOR INJECTION Dosage form: TABLET
Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH TABLET CONTAINS:
DICLOFENAC POTASSIUM PLERIXAFOR 20 mg/ml ROFLUMILAST 500,0 pg
25,0 mg
1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7
Applicant: NOVARTIS SA (PTY) LTD Applicant: GENZYME Applicant: NYCOMED (PTY) LTD
BIOPHARMACEUTICALS
SOUTH AFRICA (PTY) LTD
Manufacturer: RP SCHERER GmbH & Co. KG, Manufacturer: Manufacturer:
PATHEON UK LTD, SWINDON, NYCOMED GmbH,
EBERBACH/BADEN, GERMANY WILTSHIRE, UNITED ORANIENBURG, GERMANY
KINGDOM
Packer: CATALENT GERMANY Packer: Packer:
SCHORNDORF GmbH, WILTSHIRE, UNITED ORANIENBURG, GERMANY
STEINBEISSTRASSE, KINGDOM
SCHORNDORF, GERMANY GENZYME LTD, HAVERHILL,
SUFFOLK, UNITED KINGDOM
Laboratory: FPRC: RP SCHERER GmbH & Co. KG, Laboratory: FPRC: Laboratory: FPRC
EBERBACH/BADEN, GERMANY WILTSHIRE, UNITED ORANIENBURG, GERMANY
SANDOZ SA (PTY) LTD, KINGDOM
SPARTAN, KEMPTON PARK, GENZYME LTD, HAVERHILL,
RSA SUFFOLK, UNITED KINGDOM
M & L LABORATORY CONSULTING CHEMICAL
SERVICES, LIMBRO BUSINESS LABORATORIES, ATLASVILLE,
PARK, SANDTON, RSA BOKSBURG, RSA

FPRR: FPRR: FPRR:
NOVARTIS SA (PTY) LTD, GENZYME NYCOMED (PTY) LTD,
SPARTAN, KEMPTON PARK, BIOPHARMACEUTICALS, BRYANSTON, RSA
RSA BRYANSTON, GAUTENG, RSA
24 months 36 months
MRF 15 MRF15 IF 15

Name of medicine: SINTAIR 4 mg Name of medicine: SINTAIR 5 mg Name of medicine: SINTAIR 10 mg
Dosage form: CHEWABLE TABLET Dosage form: CHEWABLE TABLET Dosage form: TABLET
MONTELUKAST SODIUM MONTELUKAST SODIUM MONTELUKAST SODIUM
MONTELUKAST 4,0 mg MONTELUKAST 5,0 mg MONTELUKAST 10,0 mg
1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7, 8
Applicant: PHARMA DYNAMICS (PTY) LTD Applicant: PHARMA DYNAMICS (PTY) Applicant: PHARMA DYNAMICS (PTY)
LTD LTD
Manufacturer. TORRENT PHARMACEUTICALS Manufacturer: TORRENT Manufacturer. TORRENT
LIMITED, INDRAD, MEHSANA, PHARMACEUTICALS LIMITED, PHARMACEUTICALS
INDIA INDRAD, MEHSANA, INDIA LIMITED, INDRAD,
MEHSANA, INDIA
Packer: TORRENT PHARMACEUTICALS Packer: Packer:
TORRENT TORRENT
MEHSANA, INDIA
Laboratory: FPRC: TORRENT PHARMACEUTICALS Laboratory: FPRC: TORRENT Laboratory: FPRC TORRENT
CONSULTING CHEMICAL CONSULTING CHEMICAL MEHSANA, INDIA
LABORATORIES (PTY) LABORATORIES (PTY) CONSULTING CHEMICAL
LTD,ATLASVILLE, BOKSBURG, LTD,ATLASVILLE, BOKSBURG, LABORATORIES (PTY)
RSA RSA LTD,ATLASVILLE,
BOKSBURG, RSA
FPRR: PHARMA DYNAMICS (PTY) FPRR: FPRR:
PHARMA DYNAMICS (PTY) PHARMA DYNAMICS (PTY)
LTD, SILVERWOOD CLOSE, LTD, SILVERWOOD CLOSE, LTD, SILVERWOOD CLOSE,
WESTLAKE, RSA WESTLAKE, RSA WESTLAKE, RSA
24 months (Provisional) 24 months (Provisional)
No. 36136
31
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MRF 15 MRF15 MRF 15

Name of medicine: CIPLA CAPREOMYCIN Name of medicine: MEDPRO CAPREOMYCIN Name of medicine: GLENMONT 4
No. 36136
Dosage form: POWDER FOR INJECTION Dosage form: POWDER FOR INJECTION Dosage form: CHEWABLE TABLET
Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH CHEWABLE TABLET
CAPREOMYCIN SULPHATE CAPREOMYCIN SULPHATE CONTAINS:
EQUIVALENT TO EQUIVALENT TO Montelukast sodium
CAPREOMYCIN 1,0 g CAPREOMYCIN 1,0 g equivalent to Montelukast
4,0 mg
Applicant: CIPLA MEDPRO (PTY) LTD Applicant: CIPLA LIFE SCIENCES (PTY) Applicant: GLENMARK
LTD PHARMACEUTICALS SA
(PTY) LTD
Manufacturer: CIPLA LTD. (UNIT IX), VERNA, Manufacturer: CIPLA LTD. (UNIT IX), VERNA, Manufacturer: GLENMARK
GOA, INDIA GOA, INDIA PHARMACEUTICALS
LIMITED, BARDEZ, GOA,
INDIA
Packer: CIPLA LTD. (UNIT IX), VERNA, Packer: Packer: GLENMARK
CIPLA LTD. (UNIT IX), VERNA,
INDIA
Laboratory: FPRC: CIPLA LTD. (UNIT IX), VERNA, Laboratory: FPRC: CIPLA. LTD. (UNIT IX), VERNA, Laboratory: FPRC GLENMARK
INDIA
SABS COMMERCIAL (PTY)
LTD PHARMACEUTICAL
CHEMISTRY
DEPARTMENT;
GROENKLOOF, PRETORIA,
RSA
FPRR: CIPLA MEDPRO, ROSENPARK, FPRR: CIPLA LIFE SCIENCES, FPRR: GLENMARK
BELVILLE, RSA ROSENPARK, BELVILLE, RSA PHARMACEUTICALS SA
(PTY) LTD, MIDRAND, RSA
MRF 15 MRF15 MRF 15
Name of medicine: GLENMONT 5 Name of medicine: GLENMONT 10 Name of medicine: MUCO GO 200 EFFERVESCENT
TABLETS
Dosage form: CHEWABLE TABLET Dosage form: TABLET Dosage form: EFFERVESCENT TABLET
Active ingredients: EACH CHEWABLE TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS:
CONTAINS: Montelukast sodium equivalent to ACETYLCYSTEINE 200,0 mg
Montelukast sodium equivalent to Montelukast 10,0 mg
Montelukast 5,0 mg
Applicant: GLENMARK PHARMACEUTICALS Applicant: GLENMARK PHARMACEUTICALS Applicant: ACTOR PHARMA (PTY) LTD
SA (PTY) LTD SA (PTY) LTD
Manufacturer: GLENMARK PHARMACEUTICALS Manufacturer: GLENMARK PHARMACEUTICALS Manufacturer: TEMMLER PHARMA GmbH & CO.
LIMITED, BARDEZ, GOA, INDIA LIMITED, BARDEZ, GOA, INDIA KG, MARBURG, GERMANY
Packer: GLENMARK PHARMACEUTICALS Packer: GLENMARK PHARMACEUTICALS Packer: TEMMLER PHARMA GmbH & CO.
PACKAGING (PTY) LTD,
LONGDALE, INDUSTRIA, RSA
TECHNIKON LABORATORIES (PTY)
LTD, ROBERTVILLE, FLORIDA, RSA
Laboratory: FPRC: GLENMARK PHARMACEUTICALS Laboratory: FPRC: GLENMARK PHARMACEUTICALS Laboratory: FPRC TEMMLER PHARMA GmbH & CO.
SABS COMMERCIAL (PTY) LTD SABS COMMERCIAL (PTY) LTD SABS COMMERCIAL (PTY) LTD
PHARMACEUTICAL CHEMISTRY PHARMACEUTICAL CHEMISTRY PHARMACEUTICAL CHEMISTRY
DEPARTMENT; GROENKLOOF, DEPARTMENT; GROENKLOOF, DEPARTMENT, GROENKLOOF,
PRETORIA, RSA PRETORIA, RSA PRETORIA, RSA
CONSULTING CHEMICAL
ATLASVILLE, BOKSBURG, RSA

LTD, ROBERTVILLE EXTENSION,
FLORIDA, RSA
FPRR: GLENMARK PHARMACEUTICALS FPRR: GLENMARK PHARMACEUTICALS FPRR: ACTOR PHARMA (PTY) LTD,
SA (PTY) LTD, MIDRAND, RSA SA (PTY) LTD, MIDRAND, RSA HALFWAY HOUSE, MIDRAND, RSA
Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Shelf-life: 60 months (Aluminium tubes)
36 months (Polyproylene containers)
No. 36136
33
34
MRF 15 MRF15
Registration number: 44/10.1/0927 Registration number: 46/20.2.8/0760 Registration number: 46/20.2.8/0682

Name of medicine: MUCATAK 200 EFFERVESCENT Name of medicine: LAMIVUDINE WINTHROP 150 mg Name of medicine: ATAZOR 300
TABLETS
No. 36136
Dosage form: EFFERVESCENT TABLET Dosage form: TABLET Dosage form: CAPSULE
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH CAPSULE CONTAINS:
ACETYLCYSTEINE 200,0 mg LAMIVUDINE 150,0 mg ATAZANAVIR SULPHATE
EQUIVALENT TO
ATAZANAVIR 300,0 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1,2,3,4,5,6,7 Conditions of 1,2,3,4,5,6,7
registration:
Applicant ACTOR PHARMA (PTY) LTD Applicant WINTHROP PHARMACEUTICALS (PTY) Applicant: EMCURE PHARMACEUTICALS SA
LTD
(PTY) LTD
Manufacturer: TEMMLER PHARMA GmbH & CO. Manufacturer: HETERO DRUGS LIMITED, UNIT III, Manufacturer: EMCURE PHARMACEUTICALS INDIA,
KG, MARBURG, GERMANY JEEDIMETLA, HYDERABAD, INDIA HINJWADI, PUNE, INDIA
WINTHROP PHARMACEUTICALS (PTY)
LTD, WALTLOO, PRETORIA, RSA
Packer: TEMMLER PHARMA GmbH & CO. Packer: HETERO DRUGS LIMITED, UNIT III, Packer: EMCURE PHARMACEUTICALS INDIA,
DIVPHARM MANUFACTURING AND WINTHROP PHARMACEUTICALS (PTY)
PACKAGING (PTY) LTD,
LONGDALE, INDUSTRIA, RSA
Laboratory: FPRC: TEMMLER PHARMA GmbH & CO. Laboratory: FPRC: HETERO DRUGS LIMITED, UNIT III, Laboratory: FPRC: EMCURE PHARMACEUTICALS INDIA,
SABS COMMERCIAL (PTY) LTD WINTHROP PHARMACEUTICALS (PTY)
CONSULTING CHEMICAL
PHARMACEUTICAL CHEMISTRY LABORATORIES, ATLASVILLE,
DEPARTMENT, GROENKLOOF, BOKSBURG, RSA
PRETORIA, RSA SEDEK AGRIKEM cc,
CONSULTING CHEMICAL SILVERTONDALE, PRETORIA, RSA
LABORATORIES (PTY) LTD, PHARMASPEC CONSULTING
ATLASVILLE, BOKSBURG, RSA LABORATORIES, FERNDALE,
TECHNIKON LABORATORIES (PTY) RANDBURG, RSA
LTD, ROBERTVILLE EXTENSION,

FLORIDA, RSA
FPRR: ACTOR PHARMA (PTY) LTD, FPRR: WINTHROP PHARMACEUTICALS (PTY) FPRR: EMCURE PHARMACEUTICALS SA
HALFWAY HOUSE, MIDRAND, RSA LTD, WALTLOO, PRETORIA, RSA (PTY) LTD, MONDEOR,
JOHANNESBURG, RSA
LTD, MIDRAND, RSA
Shelf-life: 60 months (Aluminium tubes) Shelf-life: 36 months Shelf-life: 24 months

36 months (Polyproylene containers)
MRF 15 MRF15 MRF 15

Name of medicine: ACCORD TEMOZOLOMIDE 5 Name of medicine: ACCORD TEMOZOLOMIDE 20 Name of medicine: ACCORD TEMOZOLOMIDE
100
Dosage form: CAPSULE Dosage form: CAPSULE Dosage form: CAPSULE
Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH CAPSULE
TEMOZOLOMIDE 5,0 mg TEMOZOLOMIDE 20,0 mg CONTAINS:
Applicant: ACCORD HEALTHCARE (PTY) Applicant: ACCORD HEALTHCARE (PTY) Applicant: ACCORD HEALTHCARE
LTD LTD (PTY) LTD
Manufacturer: INTAS PHARMACEUTICALS Manufacturer. INTAS PHARMACEUTICALS Manufacturer: INTAS PHARMACEUTICALS
LIMITED, VILLAGE MATODA, LIMITED, VILLAGE MATODA, LIMITED, VILLAGE
TALUKA, AHMEDABAD, TALUKA, AHMEDABAD, MATODA, TALUKA,
GUJARAT, INDIA GUJARAT, INDIA AHMEDABAD, GUJARAT,
INDIA
Packer: INTAS PHARMACEUTICALS Packer: INTAS PHARMACEUTICALS Packer: INTAS PHARMACEUTICALS
INDIA
Laboratory: FPRC: INTAS PHARMACEUTICALS Laboratory: FPRC: INTAS PHARMACEUTICALS Laboratory: FPRC INTAS PHARMACEUTICALS
CONSULTING CHEMICAL CONSULTING CHEMICAL INDIA
LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD, CONSULTING CHEMICAL
ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, LABORATORIES (PTY) LTD,
PHARMASPEC CONSULTING RSA ATLASVILLE, BOKSBURG,
LABORATORIES, FERNDALE, PHARMASPEC CONSULTING RSA

RANDBURG, RSA LABORATORIES, FERNDALE, PHARMASPEC
RANDBURG, RSA CONSULTING
LABORATORIES,
FERNDALE, RANDBURG,
RSA
FPRR: ACCORD HEALTHCARE (PTY) FPRR: ACCORD HEALTHCARE (PTY) FPRR: ACCORD HEALTHCARE
LTD, RIVONIA, GAUTENG, RSA LTD, RIVONIA, GAUTENG, RSA (PTY) LTD, RIVONIA,
GAUTENG, RSA
No. 36136
35
36
MRF 15 MRF15 MRF 15

Name of medicine: ACCORD TEMOZOLOMIDE 250 Name of medicine: TEMINTAS 5 Name of medicine: TEMINTAS 20
No. 36136
Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH CAPSULE
TEMOZOLOMIDE 250,0 mg TEMOZOLOMIDE 5,0 mg CONTAINS:
Conditions of 1, 2, 3, 4, 5, 6, 7, 8 Conditions of 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8
Applicant: ACCORD HEALTHCARE (PTY) Applicant: ACCORD HEALTHCARE (PTY) Applicant: ACCORD HEALTHCARE
LTD LTD (PTY) LTD
Manufacturer: INTAS PHARMACEUTICALS Manufacturer: INTAS PHARMACEUTICALS Manufacturer: INTAS PHARMACEUTICALS
INDIA
INDIA
CONSULTING CHEMICAL CONSULTING CHEMICAL INDIA
LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD, CONSULTING CHEMICAL
ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, LABORATORIES (PTY) LTD,
PHARMASPEC CONSULTING RSA ATLASVILLE, BOKSBURG,
LABORATORIES, FERNDALE, PHARMASPEC CONSULTING RSA
RANDBURG, RSA LABORATORIES, FERNDALE, PHARMASPEC

LABORATORIES,
FERNDALE, RANDBURG,
RSA
FPRR: ACCORD HEALTHCARE (PTY) FPRR: ACCORD HEALTHCARE (PTY) FPRR: ACCORD HEALTHCARE
LTD, RIVONIA, GAUTENG, RSA LTD, RIVONIA, GAUTENG, RSA (PTY) LTD, RIVONIA,
GAUTENG, RSA
MRF 15 MRF15 MRF 15
Registration number: 44/26/0966 Registration number: 44/26/0967 Registration number: 44/7.1.5/1049

Name of medicine: TEMINTAS 100 Name of medicine: TEMINTAS 250 Name of medicine: LEVITRA ODT 10
Dosage form: CAPSULE Dosage form: CAPSULE Dosage form: TABLET
Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH TABLET CONTAINS:
TEMOZOLOMIDE 100,0 mg TEMOZOLOMIDE 250,0 mg VARDENAFIL
HYDROCHLORIDE
EQUIVALENT TO VARDENAFIL
10,0 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7
Applicant: ACCORD HEALTHCARE (PTY) Applicant: ACCORD HEALTHCARE (PTY) Applicant. BAYER (PTY) LTD
LTD LTD
Manufacturer: INTAS PHARMACEUTICALS Manufacturer: INTAS PHARMACEUTICALS Manufacturer: BAYER SCHERING PHARMA
LIMITED, VILLAGE MATODA, LIMITED, VILLAGE MATODA, AG, LEVERKUSEN, GERMANY
TALUKA, AHMEDABAD, TALUKA, AHMEDABAD,
Packer: INTAS PHARMACEUTICALS Packer: INTAS PHARMACEUTICALS Packer: BAYER SCHERING PHARMA
TALUKA, AHMEDABAD, TALUKA, AHMEDABAD, BRECON PHARMACEUTICAL
GUJARAT. INDIA GUJARAT, INDIA LTD, HAY-ON-WYE,
HEREFORD, UNITED KINGDOM
Laboratory: FPRC: INTAS PHARMACEUTICALS Laboratory: FPRC: INTAS PHARMACEUTICALS Laboratory: FPRC BAYER SCHERING PHARMA
TALUKA, AHMEDABAD, TALUKA, AHMEDABAD, SABS COMMERCIAL (PTY) LTD
GUJARAT, INDIA GUJARAT, INDIA PHARMACEUTICAL
CONSULTING CHEMICAL CONSULTING CHEMICAL CHEMISTRY DEPARTMENT,
LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD, GROENKLOOF, PRETORIA,
ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, RSA
PHARMASPEC CONSULTING RSA RESEARCH INSTITUTE FOR

LABORATORIES, FERNDALE, PHARMASPEC CONSULTING INDUSTRIAL PHARMACY,
RANDBURG, RSA LABORATORIES, FERNDALE, NORTH-WEST UNIVERSITY,
RANDBURG, RSA POTCHEFSTROOM, RSA
FPRR: ACCORD HEALTHCARE (PTY) FPRR: ACCORD HEALTHCARE (PTY) FPRR: BAYER (PTY) LTD, ISANDO,
LTD, RIVONIA, GAUTENG, RSA LTD, RIVONIA, GAUTENG, RSA GAUTENG, RSA

No. 36136
37
38
MRF 15 MRF15 MRF 15

Name of medicine: Name of medicine: Name of medicine:
No. 36136
ACCORD NALTREXONE NALTIMA QUETIPINE MEDPRO 25

NALTREXONE NALTREXONE QUETIAPINE FUMARATE
HYDROCHLORIDE 50,0 mg HYDROCHLORIDE 50,0 mg EQUIVALENT TO QUETIAPINE
25,0 mg
Applicant: ACCORD HEALTHCARE (PTY) Applicant: ACCORD HEALTHCARE (PTY) Applicant: CIPLA MEDPRO (PTY) LTD
LTD LTD
Manufacturer: INTAS PHARMACEUTICALS Manufacturer: INTAS PHARMACEUTICALS Manufacturer: CIPLA LTD. (UNIT III), VERNA,
LIMITED, VILLAGE MATODA, LIMITED, VILLAGE MATODA, SALCETTE, GOA, INDIA
Packer: INTAS PHARMACEUTICALS Packer: INTAS PHARMACEUTICALS Packer: CIPLA LTD. (UNIT III), VERNA,
Laboratory: FPRC: INTAS PHARMACEUTICALS Laboratory: FPRC: INTAS PHARMACEUTICALS Laboratory: FPRC CIPLA LTD. (UNIT III), VERNA,
CONSULTING CHEMICAL CONSULTING CHEMICAL
LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD,
ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG,
PHARMASPEC CONSULTING RSA
LABORATORIES, FERNDALE, PHARMASPEC CONSULTING
RANDBURG, RSA LABORATORIES, FERNDALE,

RANDBURG, RSA
FPRR: ACCORD HEALTHCARE (PTY) FPRR: ACCORD HEALTHCARE (PTY) FPRR: CIPLA MEDPRO, ROSENPARK,
LTD, RIVONIA, GAUTENG, RSA LTD, RIVONIA, GAUTENG, RSA BELVILLE, RSA

MRF 15 MRF15 2F 15

Name of medicine: QUETIPINE MEDPRO 100 Name of medicine: QUETIPINE MEDPRO 150 Name of medicine: QUETIPINE MEDPRO 200
QUETIAPINE FUMARATE QUETIAPINE FUMARATE QUETIAPINE FUMARATE
EQUIVALENT TO QUETIAPINE EQUIVALENT TO QUETIAPINE EQUIVALENT TO
100,0 mg 150,0 mg QUETIAPINE 200,0 mg
1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7
Applicant: CIPLA MEDPRO (PTY) LTD Applicant: CIPLA MEDPRO (PTY) LTD Applicant: CIPLA MEDPRO (PTY) LTD
Manufacturer. Manufacturer: Manufacturer:
CIPLA LTD. (UNIT III), VERNA, CIPLA LTD. (UNIT III), VERNA, CIPLA LTD. (UNIT III),
SALCETTE, GOA, INDIA SALCETTE, GOA, INDIA VERNA, SALCETTE, GOA,
INDIA
Packer: CIPLA LTD. (UNIT III), VERNA, Packer: Packer:
CIPLA LTD. (UNIT III), VERNA, CIPLA LTD. (UNIT III),
INDIA
Laboratory: FPRC: CIPLA LTD. (UNIT III), VERNA, Laboratory: FPRC: Laboratory: FPRC
CIPLA LTD. (UNIT III), VERNA, CIPLA LTD. (UNIT III),
INDIA
FPRR: FPRR: FPRR:
CIPLA MEDPRO, ROSENPARK, CIPLA MEDPRO, ROSENPARK, CIPLA MEDPRO,
BELVILLE, RSA BELVILLE, RSA ROSENPARK, BELVILLE,
RSA

24 months 24 months
No. 36136
39
40
No. 36136
MRF 15 MRF15 F 15

Name of medicine: QUETIAPINE MEDPRO 300 Name of medicine: Name of medicine:
CIPLA QUETIAPINE 25 CIPLA QUETIAPINE 100
EQUIVALENT TO QUETIAPINE EQUIVALENT TO QUETIAPINE EQUIVALENT TO QUETIAPINE
300,0 mg 25,0 mg 100,0 mg
1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7
Manufacturer: Manufacturer: Manufacturer.
CIPLA LTD. (UNIT III), VERNA, CIPLA LTD. (UNIT III), VERNA, CIPLA LTD. (UNIT III), VERNA,
SALCETTE, GOA, INDIA SALCETTE, GOA, INDIA SALCETTE, GOA, INDIA
Packer: Packer: Packer:
Laboratory: FPRC: Laboratory: FPRC: Laboratory: FPRC
FPRR: FPRR: FPRR:
CIPLA MEDPRO, ROSENPARK, CIPLA MEDPRO, ROSENPARK, CIPLA MEDPRO, ROSENPARK,
BELVILLE, RSA BELVILLE, RSA BELVILLE, RSA

24 months 24 months
MRF 15 MRF15 MRF 15
Name of medicine: CIPLA QUETIAPINE 150 Name of medicine: CIPLA QUETIAPINE 200 Name of medicine: CIPLA QUETIAPINE 300
EQUIVALENT TO QUETIAPINE EQUIVALENT TO QUETIAPINE EQUIVALENT TO QUETIAPINE
150,0 mg 200,0 mg 300,0 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: Conditions of registration:
1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7
Manufacturer: CIPLA LTD. (UNIT III), VERNA, Manufacturer: Manufacturer:
CIPLA LTD. (UNIT III), VERNA, CIPLA LTD. (UNIT III), VERNA,
Packer: CIPLA LTD. (UNIT III), VERNA, Packer: Packer:
Laboratory: FPRC: CIPLA LTD (UNIT III), VERNA, Laboratory: FPRC: Laboratory: FPRC
FPRR: CIPLA MEDPRO, ROSENPARK, FPRR: FPRR:
CIPLA MEDPRO, ROSENPARK, CIPLA MEDPRO, ROSENPARK,
BELVILLE, RSA BELVILLE, RSA BELVILLE, RSA

Date of registration:
26 OCTOBER 2012 Date of registration: 26 OCTOBER 2012 Date of registration: 26 OCTOBER 2012
No. 36136
41
42
MRF 15 MRF15 MRF 15

No. 36136

Name of medicine: IRINOTECAN SAFELINE 40 mg/2 ml Name of medicine: IRINOTECAN SAFELINE Name of medicine: JEVTAMA
100 mg/5 ml
Dosage form: SOLUTION FOR INFUSION Dosage form: SOLUTION FOR INFUSION Dosage form: CONCENTRATE FOR SOLUTION FOR
INFUSION AND SOLVENT FOR
DILUTION
Active ingredients: EACH 2,0 ml SOLUTION CONTAINS: Active ingredients: EACH 5,0 ml SOLUTION Active ingredients: EACH VIAL CONTAINS:
Irinotecan hydrochloride trihydrate CONTAINS: CABAZITAXEL 60,0 mg
40,0 mg Irinotecan hydrochloride trihydrate
100,0 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7
registration:
Applicant: SAFELINE PHARMACEUTICALS Applicant: SAFELINE PHARMACEUTICALS Applicant: SANOFI-AVENTIS SOUTH AFRICA
(PTY) LTD (PTY) LTD (PTY) LTD
Manufacturer: VIANEX S.A, PALINI ATTICI, Manufacturer: VIANEX S.A, PALINI ATTICI, Manufacturer: AVENTIS PHARMA DAGENHAM,
GREECE GREECE ESSEX, UK
Packer: VIANEX S.A, PALINI ATTIC!, Packer: VIANEX S.A, PALINI ATTICI, Packer: AVENTIS PHARMA DAGENHAM,
Laboratory: FPRC: VIANEX SA, PALINI ATTIC!, Laboratory: FPRC: VIANEX S.A, PALINI ATTICI, Laboratory: FPRC AVENTIS PHARMA DAGENHAM,
M&L LABORATORY SERCICES M&L LABORATORY SERCICES WINTHROP PHARMACEUTICALS
(PTY) LTD, LIMBRO BUSINESS (PTY) LTD, LIMBRO BUSINESS (PTY) LTD, WALTLOO, PRETORIA,
PARK, SANDTON, RSA PARK, SANDTON, RSA RSA
M&L LABORATORY SERVICES,
RSA
FPRR: SAFELINE PHARMACEUTICALS FPRR: SANOFI-AVENTIS SOUTH AFRICA
(PTY) LTD, FLORIDA, RSA FPRR: SAFELINE PHARMACEUTICALS (PTY) LTD, MIDRAND, RSA
(PTY) LTD, FLORIDA, RSA WINTHROP PHARMACEUTICALS

(PTY) LTD, WALTLOO, PRETORIA,
RSA
MRF 15 MRF15 IF 15
Registration number: 46/20.2.8/0005 Registration number: 46/20.2.8/0010 Registration number 46/20.2.8/0011
Name of medicine: ACRIPTAZ 200 mg Name of medicine: LAZENA 150 Name of medicine: LAZENA 300
NEVIRAPINE 200,0 mg LAMIVUDINE 150,0 mg LAMIVUDINE 300 mg
Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: Conditions of registration:

1,2,3,4,5,6,7 1,2,3,4,5,6,7
Applicant: MYLAN (PTY) LTD Applicant: MYLAN (PTY) LTD Applicant: MYLAN (PTY) LTD
Manufacturer MATRIX LABORATORIES LIMITED, Manufacturer. MATRIX LABORATORIES LIMITED, Manufacturer MATRIX LABORATORIES LIMITED,
SINNAR, NASHIK, MAHARASHTRA, SINNAR, NASHIK, MAHARASHTRA, SINNAR, NASHIK, MAHARASHTRA,
INDIA INDIA INDIA
Packer: MATRIX LABORATORIES LIMITED, Packer Packer:
MATRIX LABORATORIES LIMITED, MATRIX LABORATORIES LIMITED,
INDIA INDIA INDIA
Laboratory: FPRC: MATRIX LABORATORIES LIMITED, Laboratory: FPRC: MATRIX LABORATORIES LIMITED, Laboratory: FPRC MATRIX LABORATORIES LIMITED,
INDIA INDIA INDIA
LABORATORIES, ATLASVILLE, LABORATORIES, ATLASVILLE, LABORATORIES, ATLASVILLE,
BOKSBURG, RSA BOKSBURG, RSA BOKSBURG, RSA
ACORN PHARMACEUTICALS (PTY) ACORN PHARMACEUTICALS (PTY) ACORN PHARMACEUTICALS (PTY)
LTD, NORTH RIDING, LTD, NORTH RIDING, LTD, NORTH RIDING,
PHARMASPEC CONSULTING PHARMASPEC CONSULTING PHARMASPEC CONSULTING
LABORATORIES, FERNDALE, LABORATORIES, FERNDALE, LABORATORIES, FERNDALE,
RANDBURG, RSA RANDBURG, RSA RANDBURG, RSA
FPRR:
MYLAN (PTY) LTD, FPRR: MYLAN (PTY) LTD, FPRR: MYLAN (PTY) LTD,
MODDERFONTEIN, MODDERFONTEIN, MODDERFONTEIN,

No. 36136
43
44
No. 36136
MRF 15 MRF15 F 15

Name of medicine: DUMIVA Name of medicine: HETERO TENOFOVIR 300 mg Name of medicine: DIVUWIN
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS:TENOFOVIR Active ingredients: EACH TABLET CONTAINS:
ABACAVIR SULPHATE EQUIVALENT TO DISOPROXIL FUMARATE 300,0 mg LAMIVUDINE 150,0 mg
ABACAVIR 600,0 mg ZIDOVUDINE 300,0 mg
LAMIVUDINE 300,0 mg
Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7,8
Applicant: MYLAN (PTY) LTD Applicant: HETERO DRUGS SA Applicant: WINTHROP PHARMACEUTICALS (PTY)
LTD
Manufacturer: MATRIX LABORATORIES LIMITED, Manufacturer. HETERO DRUGS LIMITED, UNIT III, Manufacturer HETERO DRUGS LIMITED, UNIT III,
SINNAR, NASHIK, MAHARASHTRA, INDIA JEEDIMETLA, HYDERABAD, INDIA JEEDIMETLA, HYDERABAD, INDIA
Packer: MATRIX LABORATORIES LIMITED, Packer. HETERO DRUGS LIMITED, UNIT III, Packer: HETERO DRUGS LIMITED, UNIT III,
Laboratory: FPRC: MATRIX LABORATORIES LIMITED, Laboratory: FPRC: HETERO DRUGS LIMITED, UNIT III, Laboratory: FPRC HETERO DRUGS LIMITED, UNIT III,
CONSULTING CHEMICAL WINTHROP PHARMACEUTICALS (PTY)
LABORATORIES, ATLASVILLE, LTD, WALTLOO, PRETORIA, RSA
BOKSBURG, RSA
ACORN PHARMACEUTICALS (PTY) LTD,
NORTH RIDING, JOHANNESBURG, RSA
PHARMASPEC SONSULTING
LABORATORIES, FERNDALE,
RANDBURG, RSA
FPRR: MYLAN (PTY) LTD, MODDERFONTEIN, FPRR: HETERO DRUGS SA, JEAN PARK FPRR: WINTHROP PHARMACEUTICALS (PTY)
JOHANNESBURG, RSA CHAMBERS, CENTURION, RSA LTD, MIDRAND, RSA

MRF 15 MRF15 F 15

Name of medicine: DEXDOM1TOR Name of medicine: Name of medicine:
VARI MICONAZOLE 2 % m/m ALLERCHROM EYE DROPS
ORAL GEL
Dosage form: SOLUTION FOR INJECTION Dosage form: ORAL GEL Dosage form: EYEDROPS
Active ingredients: EACH 1,0 ml SOLUTION Active ingredients: Active ingredients:
EACH 1,0 g GEL CONTAINS: EACH 1,0 ml CONTAINS:
CONTAINS: MICONAZOLE 20,0 mg SODIUM CROMOGLICATE
DEXMEDETOMIDINE HCI 0,5 mg 20,0 mg
1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7
Applicant: PFIZER LABORATORIES (PTY) Applicant: LEBASI PHARMCEUTICALS CC Applicant: PHARMACARE LIMITED
LTD
Manufacturer: ORION CORPORATION ORION Manufacturer: Manufacturer:
VARICHEM LABORATORIES, FDC LIMITED, WALUJ,
PHARMA, TURKU, FINLAND HARARE, ZIMBABWE AURANGABAD, INDIA
Packer: ORION CORPORATION ORION Packer: Packer:
Laboratory: FPRC: ORION CORPORATION ORION Laboratory: FPRC: Laboratory: FPRC:
SABS COMMERCIAL (PTY) LTD, RESEARCH INSTITUTE FOR RESEARCH INSTITUTE FOR
PHARMACEUTICAL CHEMISTRY INDUSTRIAL PHARMACY, INDUSTRIAL
DEPARTMENT, GROENKLOOF, NORTH-WEST UNIVERSITY, PHARMACY, NORTH WEST
PRETORIA, RSA POTCHEFSTROOM, RSA UNIVERSITY,
M&L LABORATORY SERVICES, SABS COMMERCIAL (PTY) LTD POTCHEFSTROOM, RSA
LIMBRO BUSINESS PARK, PHARMACEUTICAL PHARMACARE LIMITED,
SANDTON, RSA CHEMISTRY DEPARTMENT; KORSTEN, PORT ELIZABETH,
CONSULTING CHEMICAL GROENKLOOF, PRETORIA, RSA
LABORATORIES, ATLASVILLE, RSA ASPEN PHARMACARE EAST
BOKSBURG, RSA LONDON, WILSONIA, EAST
LONDON, RSA
FPRR: PFIZER LABORATORIES (PTY) FPRR: FPRR:
LEBASI PHARMACEUTICALS PHARMACARE LIMITED,
LTD, SANDTON, RSA CC, POTCHEFSTROOM, RSA WOODMEAD, SANDTON, RSA
PHARMACARE LIMITED,
KORSTEN, PORT ELIZABETH,
RSA
Date of registration: 07 DECEMBER 2012 Date of registration: Date of registration:
07 DECEMBER 2012 07 DECEMBER 2012
No. 36136
45
46
MRF 15 MRF15 ORF 15
Registration number: 38/11.5/0338 Registration number: A40/2.5/0342 Registration number: A40/5.7.1/0375

Name of medicine: SUPERTABS NEW FORMULATION Name of medicine: EPIPROATE 400 mg/4 ml Name of medicine: ALLERCHLOR 4 mg
No. 36136
Dosage form: TABLET Dosage form: POWDER AND SOLVENT FOR Dosage form: TABLET
INJECTABLE SOLUTION
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH TABLET CONTAINS:
BISACODYL 5,0 mg SODIUM VALPROATE 400,0 mg CHLORPHENIRAMINE MALEATE
4,0 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7,8 Conditions of 1, 2, 3, 4, 5, 6, 7, 8
registration:
Applicant: PHARMACARE LIMITED Applicant: PHARMACARE LIMITED Applicant: PHARMACARE LIMITED
Manufacturer: PHARMACARE LIMITED, KORSTEN, Manufacturer: LABORATORIO REIG JOFRE S.A., SAN Manufacturer: PHARMACARE LIMITED, KORSTEN,
PORT ELIZABETH, RSA JOAN DESPI, BARCELONA, SPAIN PORT ELIZABETH, RSA
ASPEN PHARMACARE EAST ASPEN PHARMACARE EAST
LONDON, WILSONIA, EAST LONDON, LONDON (PTY) LTD, WILSONIA, EAST
RSA LONDON, RSA
Packer: PHARMACARE LIMITED, KORSTEN, Packer: LABORATORIO REIG JOFRE S.A., SAN Packer: PHARMACARE LIMITED, KORSTEN,
PORT ELIZABETH, RSA JOAN DESPI, BARCELONA, SPAIN PORT ELIZABETH, RSA
ASPEN PHARMACARE EAST ASPEN PHARMACARE EAST
LONDON, WILSONIA, EAST LONDON, LONDON (PTY) LTD, WILSONIA, EAST
RSA LONDON, RSA
Laboratory: FPRC: PHARMACARE LIMITED, KORSTEN, Laboratory: FPRC: LABORATORIO REIG JOFRE S.A., SAN
PORT ELIZABETH, RSA JOAN DESPI, BARCELONA, SPAIN Laboratory: FPRC: SABS COMMERCIAL (PTY) LTD
ASPEN PHARMACARE EAST RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACEUTICAL CHEMISTRY
LONDON, WILSONIA, EAST LONDON, PHARMACY, NORTH-WEST UNIVERSITY, DEPARTMENT; GROENKLOOF,
RSA POTCHEFSTROOM PRETORIA, RSA
M&L LABORATORY SERVICES, LIMBRO M&L LABORATORY SERVICES,
BUSINESS PARK, SANDTON, RSA LIMBRO BUSINESS PARK, SANDTON,
SABS COMMERCIAL (PTY) LTD, RSA
PHARMACEUTICAL CHEMISTRY RESEARCH INSTITUTE FOR
DEPARTMENT, GROENKLOOF, INDUSTRIAL PHARMACY, NORTH-
PRETORIA, RSA WEST UNIVERSITY,
POTCHEFSTROOM, RSA
FPRR: PHARMACARE LIMITED, FPRC/FPRR: PHARMACARE LTD, KORSTEN, PORT FPRC/FPRR: PHARMACARE LIMITED, KORSTEN,
WOODMEAD, SANDTON, RSA ELIZABETH PORT ELIZABETH, RSA
ASPEN PHARMACARE EAST LONDON ASPEN PHARMACARE EAST
(PTY) LTD, WILSONIA, EAST LONDON, LONDON (PTY) LTD, WILSONIA, EAST
RSA LONDON, RSA
Shelf-life: 24 months FPRR: PHARMACARE LTD, WOODMEAD, FPRR: PHARMACARE LTD, WOODMEAD,
SANDTON SANDTON, RSA
Date of registration: 07 DECEMBER2012 Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional)
Date of registration: 07 DECEMBER2012 Date of registration: 07 DECEMBER2012

Registration A40/20.1.1/0390 Registration number: A40/10.2/0624 Registration number: 41/7.3/0477

number:
Name of medicine: SPEC-CIPROFLOXACIN 400 IV Name of medicine: FENOVENT Name of medicine: AUSTIGRAN 50
Dosage form: INJECTION Dosage form: LIQUID Dosage form: TABLET
Active ingredients: EACH 1,0 ml SOLUTION Active ingredients: EACH 5,0 ml CONTAINS: Active ingredients: EACH TABLET CONTAINS:
CONTAINS: FENOTEROL HYDROBROMIDE Sumatriptan succinate equivalent to
CIPROFLOXACIN LACTATE 2,5 mg Sumatriptan 50,0 mg
EQUIVALENT TO
CIPROFLOXACIN 2,0 mg
Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7
AUSTELL LABORATORIES (PTY) LTD
Applicant: SPECPHARM (PTY) LTD Applicant: PHARMACARE LIMITED Applicant:
Manufacturer: ELPEN PHARMACEUTICAL CO. Manufacturer: PHARMACARE LIMITED, Manufacturer: IPCA LABORATORIES LIMITED, DADRA
INC, PIKERMI-ATTICA, GREECE KORSTEN, PORT ELIZABETH, RSA AND NAGAR HAVELI, INDIA
ASPEN PHARMACARE EAST
LONDON, WILSONIA, EAST
LONDON, RSA
Packer: ELPEN PHARMACEUTICAL CO. Packer: PHARMACARE LIMITED, Packer: IPCA LABORATORIES LIMITED, DADRA
INC, PIKERMI-ATTICA, GREECE KORSTEN, PORT ELIZABETH, RSA AND NAGAR HAVELI, INDIA
ASPEN PHARMACARE EAST
LONDON, RSA
Laboratory: FPRC: ELPEN PHARMACEUTICAL CO. Laboratory: FPRC: SABS COMMERCIAL (PTY) LTD Laboratory: FPRC IPCA LABORATORIES LIMITED, DADRA
INC, PIKERMI-ATTICA, GREECE PHARMACEUTICAL CHEMISTRY AND NAGAR HAVELI, INDIA
DEPARTMENT GROENKLOOF, SABS COMMERCIAL (PTY) LTD,
PRETORIA, RSA PHARMACEUTICAL CHEMISTRY
M & L LABORATORY SERVICES DEPARTMENT, GROENKLOOF, PRETORIA
(PTY) LTD, LIMBRO BUSINESS M&L LABORATORY SERVICES, LIMBRO
PARK, SANDTON, RSA BUSINESS PARK, SANDTON, RSA
RESEARCH INSTITUTE FOR INSTITUTE FOR PHARMACEUTICAL
INDUSTRIAL PHARMACY, NORTH SERVICES, SILVERTONDALE, PRETORIA,
WEST UNIVERSITY, RSA

POTCHEFSTROOM, RSA
FPRR: AUSTELL
FPRR: SPECPHARM (PTY) LTD, FPRC/FPRR: PHARMACARE LIMITED, LABORATORIES (PTY)
HALFWAY HOUSE, MIDRAND, RSA KORSTEN, PORT ELIZABETH, RSA LTD, CROWN X3,
ASPEN PHARMACARE EAST JOHANNESBURG, RSA
LONDON, RSA
Shelf-life: 24 months FPRR: PHARMACARE LIMITED, Shelf-life: 36 months

WOODMEAD, SANDTON, RSA
Date of 07 DECEMBER 2012 Shelf-life: 24 months (Provisional) Date of registration 07 DECEMBER 2012
registration:
Date of registration: 07 DECEMBER 2012

No. 36136
47
48
MRF 15 MRF15 ARF 15

No. 36136
Name of medicine: AUSTIGRAN 100 Name of medicine: AUSTELL SUMATRIPTAN 50 mg Name of medicine: AUSTELL SUMATRIPTAN 100 mg
Sumatriptan succinate equivalent to Sumatriptan succinate equivalent to Sumatriptan succinate equivalent
Sumatriptan 100,0 mg Sumatriptan 50,0 mg to Sumatriptan 100,0 mg
Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7
Applicant: AUSTELL LABORATORIES (PTY) Applicant: AUSTELL LABORATORIES (PTY) Applicant: AUSTELL LABORATORIES (PTY)
LTD LTD LTD
Manufacturer: IPCA LABORATORIES LIMITED, Manufacturer: IPCA LABORATORIES LIMITED, Manufacturer: IPCA LABORATORIES LIMITED,
DADRA AND NAGAR HAVELI, DADRA AND NAGAR HAVELI, DADRA AND NAGAR HAVELI,
INDIA INDIA INDIA
Packer: IPCA LABORATORIES LIMITED, Packer: IPCA LABORATORIES LIMITED, Packer: IPCA LABORATORIES LIMITED,
INDIA INDIA INDIA
Laboratory: FPRC: IPCA LABORATORIES LIMITED, Laboratory: FPRC: IPCA LABORATORIES LIMITED, Laboratory: FPRC: IPCA LABORATORIES LIMITED,
INDIA INDIA INDIA
SABS COMMERCIAL (PTY) LTD, SABS COMMERCIAL (PTY) LTD, SABS COMMERCIAL (PTY) LTD,
PHARMACEUTICAL CHEMISTRY PHARMACEUTICAL CHEMISTRY PHARMACEUTICAL CHEMISTRY
DEPARTMENT, GROENKLOOF, DEPARTMENT, GROENKLOOF, DEPARTMENT, GROENKLOOF,
PRETORIA PRETORIA PRETORIA
M&L LABORATORY SERVICES, M&L LABORATORY SERVICES, M&L LABORATORY SERVICES,
LIMBRO BUSINESS PARK, LIMBRO BUSINESS PARK, LIMBRO BUSINESS PARK,
SANDTON, RSA SANDTON, RSA SANDTON, RSA
INSTITUTE FOR INSTITUTE FOR INSTITUTE FOR
PHARMACEUTICAL SERVICES, PHARMACEUTICAL SERVICES, PHARMACEUTICAL SERVICES,
SILVERTONDALE, PRETORIA, RSA SILVERTONDALE, PRETORIA, SILVERTONDALE, PRETORIA,
RSA RSA
FPRR: AUSTELL LABORATORIES (PTY) FPRR: AUSTELL LABORATORIES (PTY) FPRR AUSTELL LABORATORIES (PTY)
LTD, CROWN X3, LTD,CROWN X3, LTD, CROWN X3,
Date of registration: 07 DECEMBER 2012 Date of registration: 07 DECEMBER 2012 Date of registration: 07 DECEMBER 2012
MRF 15 MRF15 15
Registration number 41/7.3/0481 Registration number: 41/7.3/0482 Registration number: 41/21.5.1/0814

Name of medicine: SUMAGRAN 50 mg Name of medicine: Name of medicine:
SUMAGRAN 100 mg MYLAN DEXAMETHASONE
4 mg/ml
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH 1,0 ml CONTAINS:
Sumatriptan succinate equivalent to Sumatriptan succinate equivalent to DEXAMETHASONE SODIUM
Sumatriptan 50,0 mg Sumatriptan 100,0 mg PHOSPHATE 4 mg
Conditions of registration: Conditions of registration: Conditions of
1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7
registration:
AUSTELL LABORATORIES (PTY) AUSTELL LABORATORIES (PTY)
Applicant: Applicant: Applicant:
LTD LTD XIXIA PHARMACEUTICALS
(PTY) LTD
Manufacturer: IPCA LABORATORIES LIMITED, Manufacturer: Manufacturer:
IPCA LABORATORIES LIMITED, VIANEX S.A (PLANT A),
DADRA AND NAGAR HAVELI, DADRA AND NAGAR HAVELI, ATHENS-LAMIA,
INDIA INDIA METAMORPHOSSIS-
ATTICA, GREECE
Packer: IPCA LABORATORIES LIMITED, Packer: Packer:
IPCA LABORATORIES LIMITED, VIANEX S.A (PTY) LTD,
ATTICA, GREECE
PHARMA-Q (PTY) LTD,
INDUSTRIA,
JOHANNESBURG, RSA
Laboratory: FPRC : IPCA LABORATORIES LIMITED, Laboratory: FPRC: Laboratory: FPRC
IPCA LABORATORIES LIMITED, VIANEX SA (PLANT A),
SABS COMMERCIAL (PTY) LTD, SABS COMMERCIAL (PTY) LTD, ATTICA, GREECE
PHARMACEUTICAL CHEMISTRY PHARMACEUTICAL CHEMISTRY RESEARCH INSTITUTE FOR
DEPARTMENT, GROENKLOOF, DEPARTMENT, GROENKLOOF, INDUSTRIAL
PRETORIA, RSA PRETORIA, RSA PHARMACY,NORTH WEST
M&L LABORATORY SERVICES, M&L LABORATORY SERVICES, UNIVERSITY,

LIMBRO BUSINESS PARK, LIMBRO BUSINESS PARK, POTCHEFSTROOM, RSA
SANDTON, RSA SANDTON, RSA CONSULTING CHEMICAL
INSTITUTE FOR INSTITUTE FOR LABORATORIES,
PHARMACEUTICAL SERVICES, PHARMACEUTICAL SERVICES, ATLASVILLE, BOKSBURG,
SILVERTONDALE, PRETORIA, SILVERTONDALE, PRETORIA, RSA
RSA RSA
FPRR: AUSTELL LABORATORIES (PTY) FPRR: FPRR:
AUSTELL LABORATORIES (PTY) XIXIA PHARMACEUTICALS
LTD,CROWN X3, LTD,CROWN X3, (PTY) LTD,
JOHANNESBURG, RSA JOHANNESBURG, RSA MODDERFONTEIN,
GAUTENG, RSA
36 months 24 months
No. 36136
49
MRF 15 MRF15 v1RF 15 50
Registration 41/10.2.1/0908 Registration 42/20.1.1/0280 Registration number: 42/20.1.1/0281
number: number:
Name of medicine: DUOLIN HFA INHALER Name of MEROJECT 500 mg (POWDER FOR Name of medicine: MEROJECT 1 g (POWDER
medicine:
INJECTION) FOR INJECTION)
No. 36136
Dosage form: METERED DOSE INHALER Dosage form: STERILE POWDER FOR INJECTION Dosage form: STERILE POWDER FOR
INJECTION
Active ingredients: EACH METERED DOSE Active EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS:
CONTAINS: ingredients: MEROPENEM TRIHYDRATE MEROPENEM TRIHYDRATE
IPRATROPIUM BROMIDE EQUIVALENT TO MEROPENEM EQUIVALENT TO
MONOHYDRATE ANHYDROUS 500,0 mg MEROPENEM ANHYDROUS
EQUIVALENT TO 1 000,0 mg
IPRATROPIUM BROMIDE
20,0 pg
SALBUTAMOL SULPHATE
EQUIVALENT TO
SALBUTAMOL 100,0 pg
Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7
Applicant: CIPLA MEDPRO (PTY) LTD Applicant: PHARMA DYNAMICS (PTY) LTD Applicant: PHARMA DYNAMICS (PTY)
LTD
Manufacturer: CIPLA LIMITED GOA, UNIT (II), Manufacturer: DEMO S.A, ATHENS-LAMIA, ATHENS, Manufacturer: DEMO S.A, ATHENS-LAMIA,
VERNA , SALCETTE,GOA, GREECE ATHENS, GREECE
INDIA
Packer: CIPLA LIMITED GOA, UNIT (II), Packer: DEMO S.A, ATHENS-LAMIA, ATHENS, Packer: DEMO S.A, ATHENS-LAMIA,
VERNA , SALCETTE,GOA, GREECE ATHENS, GREECE
INDIA
Laboratory: FPRC: CIPLA LIMITED GOA, UNIT (II), Laboratory: DEMO S.A, ATHENS-LAMIA, ATHENS, Laboratory::FPRC DEMO S.A, ATHENS-LAMIA,
VERNA , SALCETTE,GOA, FPRC: GREECE ATHENS, GREECE
INDIA PHARMATHEN S.A, PALLINI, ATTIKIS, PHARMATHEN S.A, PALLINI,
GREECE ATTIKIS, GREECE
CONSULTING CHEMICAL CONSULTING CHEMICAL
LABORATORIES (PTY) LTD LABORATORIES (PTY) LTD

RSA
FPRR: CIPLA MEDPRO (PTY) LTD, FPRR: PHARMA DYNAMICS (PTY) LTD, FPRR PHARMA DYNAMICS (PTY)
ROSENPARK, RSA SILVERWOOD CLOSE, WESTLAKE, RSA LTD, SILVERWOOD CLOSE,
WESTLAKE, RSA
Date of 07 DECEMBER 2012 Date of 07 DECEMBER 2012 Date of registration: 07 DECEMBER 2012
MRF 15 MRF15 F 15
Name of medicine: TRAMAL SR 50 mg Name of medicine: ASPEN CEFPODOXIME 100 Name of medicine: ASPEN CEFPODOXIME 200
TRAMADOL HCI 50,0 mg CEFPODOXIME PROXETIL EQUIVALENT TO CEFPODOXIME PROXETIL
CEFPODOXIME 100,0 mg EQUIVALENT TO
CEFPODOXIME 200,0 mg
Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8
Applicant: JANSSEN PHARMACEUTICA (PTY) LTD Applicant: PHARMACARE LIMITED Applicant: PHARMACARE LIMITED
Manufacturer: FAMACEUTICI FORMENTI ITALY, Manufacturer: LUPIN LIMITED, MANDIDEEP, DISTRICT RAISEN, Manufacturer: LUPIN LIMITED, MANDIDEEP,
ORIGGIO, ITALY INDIA DISTRICT RAISEN, INDIA
GRUNENTHAL GmbH, STOLBERG, PHARMACARE LIMITED, KORSTEN, PORT PHARMACARE LIMITED, KORSTEN,
GERMANY ELIZABETH, RSA PORT ELIZABETH, RSA
ASPEN PHARMACARE EAST LONDON, ASPEN PHARMACARE EAST
WILSONIA, EAST LONDON, RSA LONDON, WILSONIA, EAST LONDON,
RSA
Packer: GRUNENTHAL GmbH, STOLBERG, Packer: LUPIN LIMITED, MANDIDEEP, DISTRICT RAISEN, Packer: LUPIN LIMITED, MANDIDEEP,
GERMANY INDIA DISTRICT RAISEN, INDIA
GRUNENTHAL GmbH, AACHEN, PHARMACARE LIMITED, KORSTEN, PORT PHARMACARE LIMITED, KORSTEN,
GERMANY ELIZABETH, RSA PORT ELIZABETH, RSA
SPECPHARM HOLDINGS (PTY) LTD, ASPEN PHARMACARE EAST LONDON, ASPEN PHARMACARE EAST
HALFWAY HOUSE, MIDRAND, RSA WILSONIA, EAST LONDON, RSA LONDON, WILSONIA, EAST LONDON,
RSA
Laboratory: FPRC: GRUNENTHAL GmbH, STOLBERG, Laboratory: FPRC: LUPIN LIMITED, MANDIDEEP, DISTRICT RAISEN, Laboratory: FPRC: LUPIN LIMITED, MANDIDEEP,
GERMANY INDIA DISTRICT RAISEN, INDIA
SPECPHARM HOLDINGS (PTY) LTD. SABS COMMERCIAL (PTY) LTD, SABS COMMERCIAL (PTY) LTD,
HALFWAY HOUSE, MIDRAND, RSA PHARMACEUTICAL CHEMISTRY DEPARTMENT, PHARMACEUTICAL CHEMISTRY
GROENKLOOF, PRETORIA, RSA DEPARTMENT, GROENKLOOF,
RESEARCH INSTITUTE FOR INDUSTRIAL PRETORIA, RSA
PHARMACY, NORTH-WEST UNIVERSITY, RESEARCH INSTITUTE FOR
POTCHEFSTROOM, RSA INDUSTRIAL PHARMACY, NORTH-
M&L LABORATORY SERVICES, LIMBRO WEST UNIVERSITY,
BUSINESS PARK, SANDTON, RSA POTCHEFSTROOM, RSA
M&L LABORATORY SERVICES,

RSA
FPRR: JANSSEN PHARMACEUTICA (PTY) FPRC/FPRR: PHARMACARE LIMITED, KORSTEN, PORT FPRR: PHARMACARE LIMITED, KORSTEN,
LTD, WOODMEAD, JOHANNESBURG, ELIZABETH, RSA PORT ELIZABETH, RSA
RSA ASPEN PHARMACARE EAST LONDON, ASPEN PHARMACARE EAST
WILSONIA, EAST LONDON, RSA LONDON, WILSONIA, EAST LONDON,
RSA
Shelf-life: 36 months FPRR: PHARMACARE LIMITED, WOODMEAD, SANDTON, Shelf-life: PHARMACARE LIMITED, WOODMEAD,
RSA SANDTON, RSA
Date of registration: 07 DECEMBER2012 Shelf-life: 24 months (provisional) Date of registration: 24 months (provisional)
Date of registration: 07 DECEMBER2012 07 DECEMBER2012

No. 36136
51
52
MRF 15 MRF15 F 15
No. 36136
Registration number: 45/11.4.3/0515 Registration number: 42/18.10/0538 Registration number: 42/20.1.1/0737

Name of medicine: OMEPRAZOLE SAFELINE Name of medicine: Name of medicine:
OMSAL CAPSULES FKSA CEFUROXIME 750 mg
INJECTION 40 mg
Dosage form: INJECTION Dosage form: CAPSULE Dosage form: POWDER FOR SOLUTION FOR
INJECTION
Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH VIAL CONTAINS:
OMEPRAZOLE SODIUM TAMSULOSIN CEFUROXIME SODIUM
EQUIVALENT TO HYDROCHLORIDE 0,4 mg EQUIVALENT TO
OMEPRAZOLE 40,0 mg CEFUROXIME 750,0 mg
1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7
registration:
Applicant: SAFELINE Applicant: PHARMAPLAN (PTY) LTD Applicant: BODENE (PTY) LTD (TRADING AS
PHARMACEUTICALS INTRAMED)
(PTY) LTD
Manufacturer: VIANEX S.A, PALINI Manufacturer: Manufacturer
GEDEON RICHTER LABESFAL LABORATORIES
ATTICI, GREECE ROMANIA S.A, TARGU- ALMIRO SA (FRESENIUS KABI),
MURES, ROMANIA LAGEDO, PORTUGAL
Packer: VIANEX S.A, PALINI Packer: Packer:
GEDEON RICHTER LABESFAL LABORATORIES
MURES, ROMANIA LAGEDO, PORTUGAL
Laboratory: FPRC: VIANEX S.A, PALINI Laboratory: FPRC: GEDEON RICHTER Laboratory: FPRC: LABESFAL LABORATORIES
INSTITUTE FOR MURES, ROMANIA LAGEDO, PORTUGAL
PHARMACEUTICAL CONSULTING CHEMICAL BODENE (PTY) LTD (TRADING AS
SERVICES, LABORATORIES (PTY) LTD, INTRAMED), KORSTEN, PORT
SILVERTONDALE, ATLASVILLE, BOKSBURG, ELIZABETH, RSA
PRETORIA, RSA RSA

FPRR: SAFELINE FPRR: FPRR:
PHARMAPLAN (PTY) LTD, BODENE (PTY) LTD (TRADING AS
PHARMACEUTICALS MIDRAND, RSA INTRAMED), KORSTEN, PORT
(PTY) LTD, FLORIDA, RSA ELIZABETH, RSA
24 months 24 months
Registration number: 42/21.12/0760 Registration number: 42/20.1.1/0986 Registration number: 43/7.5/0167

Name of medicine: TEVA ANASTROZOLE 1 mg Name of medicine: FKSA CEFUROXIME 1 500 mg Name of medicine: DYNATOR 10 mg
Dosage form: TABLET Dosage form: POWDER FOR SOLUTION FOR Dosage form: TABLET
INJECTION
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH TABLET CONTAINS:
ANASTROZOLE 1,0 mg CEFUROXIME SODIUM ATORVASTATIN CALCIUM EQUIVALENT
EQUIVALENT TO TO ATORVASTATIN 10,0 mg
CEFUROXIME 1 500,0 mg
Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7, 8
Applicant: TEVA PHARMACEUTICALS (PTY) Applicant: BODENE (PTY) LTD (TRADING Applicant: PHARMA DYNAMICS (PTY) LTD
LTD AS INTRAMED)
Manufacturer: TEVA PHARMACEUTICAL Manufacturer: LABESFAL LABORATORIES Manufacturer: LABORATORIOS CINFA S.A, HUARTE-
INDUSTRIES LTD, KFAR SAVA, ALMIRO SA (FRESENIUS KABI), PAMPLONA, SPAIN
ISRAEL LAGEDO, PORTUGAL
Packer: TEVA PHARMACEUTICAL Packer: LABESFAL LABORATORIES Packer: LABORATORIOS CINFA S.A, HUARTE-
INDUSTRIES LTD, ALMIRO SA (FRESENIUS KABI), PAMPLONA, SPAIN
KFAR SAVA, ISRAEL LAGEDO, PORTUGAL
TEVA PHARMACEUTICAL WORKS
PRIVATE, LIMITED COMPANY,
GODOLLO, HUNGARY
Laboratory: FPRC TEVA PHARMACEUTICAL Laboratory: FPRC: LABESFAL LABORATORIES Laboratory: FPRC: LABORATORIOS CINFA S.A, HUARTE-
INDUSTRIES LTD, KFAR SAVA, ALMIRO SA (FRESENIUS KABI), PAMPLONA, SPAIN
ISRAEL LAGEDO, PORTUGAL CONSULTING CHEMICAL LABORATORIES
CONSULTING CHEMICAL BODENE (PTY) LTD (TRADING (PTY) LTD ATLASVILLE, BOKSBURG, RSA
LABORATORIES, ATLASVILLE, AS INTRAMED), KORSTEN,
BOKSBURG, RSA PORT ELIZABETH, RSA
INSTITUTE FOR PHARMACEUTICAL
SERVICES, SIVERTONDALE,
PRETORIA, RSA
WEST UNIVERSITY,
POTCHEFSTROOM, RSA
DEPARTMENT, GROENKLOOF,
PRETORIA, RSA
FPRR: TEVA PHARMACEUTICALS (PTY) FPRR: BODENE (PTY) LTD (TRADING FPRR: PHARMA DYNAMICS (PTY) LTD,
LTD, RUIMSIG, ROODEPORT, AS INTRAMED), KORSTEN, SILVERWOOD CLOSE, WESTLAKE, RSA
GAUTENG, RSA PORT ELIZABETH, RSA
No. 36136
53
54
MRF 15 MRF15 MRF 15

No. 36136
Registration number: 43/7.5/0168 Registration number: 43/7.5/0169 Registration 43/7.5/0170

number:
Name of medicine: DYNATOR 20 mg Name of medicine: DYNATOR 40 mg Name of medicine: DYNATOR 80 mg
t
Dosage form: TABLET Dosage form: TABLE Dosage form: TABLE
Conditions of 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of 1, 2, 3, 4, 5, 6, 7, 8
Applicant: PHARMA DYNAMICS (PTY) Applicant: PHARMA DYNAMICS (PTY) LTD Applicant: PHARMA DYNAMICS (PTY) LTD
LTD
Manufacturer: LABORATORIOS CINFA S.A, Manufacturer: LABORATORIOS CINFA S.A, Manufacturer: LABORATORIOS CINFA S.A, HUARTE-
HUARTE-PAMPLONA, SPAIN HUARTE-PAMPLONA, SPAIN PAMPLONA, SPAIN
Packer: LABORATORIOS CINFA S.A, Packer: LABORATORIOS CINFA S.A, Packer: LABORATORIOS CINFA S.A, HUARTE-
Laboratory: FPRC: LABORATORIOS CINFA S.A, Laboratory: FPRC: LABORATORIOS CINFA S.A, Laboratory: FPRC: LABORATORIOS CINFA S.A, HUARTE-
LABORATORIES (PTY) LTD LABORATORIES (PTY) LTD LABORATORIES (PTY) LTD
ATLASVILLE, BOKSBURG, ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, RSA
RSA
FPRR: PHARMA DYNAMICS (PTY) FPRR: PHARMA DYNAMICS (PTY) LTD, FPRR: PHARMA DYNAMICS (PTY) LTD,
LTD, SILVERWOOD CLOSE, SILVERWOOD CLOSE, SILVERWOOD CLOSE, WESTLAKE,
WESTLAKE, RSA WESTLAKE, RSA RSA

MRF 15 MRF15 MRF 15
Name of medicine: DYNA ATORVASTATIN 10 mg Name of medicine: DYNA ATORVASTATIN 20 mg Name of medicine: DYNA ATORVASTATIN
40 mg
Applicant: PHARMA DYNAMICS (PTY) LTD Applicant: PHARMA DYNAMICS (PTY) Applicant: PHARMA DYNAMICS (PTY)
LTD LTD
Manufacturer: LABORATORIOS CINFA S.A, Manufacturer: LABORATORIOS CINFA S.A, Manufacturer: LABORATORIOS CINFA
HUARTE-PAMPLONA, SPAIN HUARTE-PAMPLONA, SPAIN S.A, HUARTE-PAMPLONA,
SPAIN
Packer: LABORATORIOS CiNFA S.A, Packer: LABORATORIOS CINFA S.A, Packer: LABORATORIOS CINFA
SPAIN
Laboratory: FPRC: LABORATORIOS CINFA S.A, Laboratory: FPRC: LABORATORIOS CINFA S.A, Laboratory: FPRC LABORATORIOS CINFA
CONSULTING CHEMICAL CONSULTING CHEMICAL SPAIN
LABORATORIES (PTY) LTD LABORATORIES (PTY) LTD CONSULTING CHEMICAL
ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, LABORATORIES (PTY) LTD
RSA ATLASVILLE, BOKSBURG,
RSA
FPRR: PHARMA DYNAMICS (PTY) FPRR: PHARMA DYNAMICS (PTY) FPRR: PHARMA DYNAMICS (PTY)
LTD, SILVERWOOD CLOSE, LTD, SILVERWOOD CLOSE, LTD, SILVERWOOD CLOSE,
WESTLAKE, RSA WESTLAKE, RSA WESTLAKE, RSA
No. 36136
55
56
MRF 15 MRF 15

Name of medicine: DYNA ATORVASTATIN Name of medicine: Name of medicine:
MYCOPHENOLATE HEXAL MYCOCEPT 500
No. 36136
80 mg 500
Dosage form: TABLE Dosage form: TABLET Dosage form: TABLET
ATORVASTATIN CALCIUM MYCOPHENOLATE MYCOPHENOLATE MOFETIL
EQUIVALENT TO MOFETIL 500,0 mg 500,0 mg
ATORVASTATIN 80,0 mg
1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7, 8
registration:
Applicant: PHARMA DYNAMICS (PTY) Applicant: SANDOZ SA (PTY) LTD Applicant: SANDOZ SA (PTY) LTD
LTD
Manufacturer: LABORATORIOS CINFA S.A, Manufacturer: Manufacturer
SANDOZ PRIVATE LIMITED, SANDOZ PRIVATE LIMITED,
HUARTE-PAMPLONA, SPAIN KALWE, NAVI MUMBAI, KALWE, NAVI MUMBAI, INDIA
INDIA
Packer LABORATORIOS CINFA S.A, Packer: Packer:
SANDOZ PRIVATE LIMITED, SANDOZ PRIVATE LIMITED,
INDIA SANDOZ SA (PTY) LTD,
SANDOZ SA (PTY) LTD, SPARTAN, KEMPTON PARK,
SPARTAN, KEMPTON RSA
PARK, RSA
Laboratory: FPRC: LABORATORIOS CINFA S.A, Laboratory: FPRC: SANDOZ PRIVATE LIMITED, Laboratory: FPRC: SANDOZ PRIVATE LIMITED,
CONSULTING CHEMICAL INDIA SANDOZ SA (PTY) LTD,
LABORATORIES (PTY) LTD SANDOZ SA (PTY) LTD, SPARTAN, KEMPTON PARK,
ATLASVILLE, BOKSBURG, SPARTAN, KEMPTON RSA
RSA PARK, RSA SABS COMMERCIAL (PTY) LTD,
SABS COMMERCIAL (PTY) PHARMACEUTICAL
LTD, PHARMACEUTICAL CHEMISTRY DEPARTMENT,
CHEMISTRY DEPARTMENT, GROENKLOOF, PRETORIA,

GROENKLOOF, PRETORIA, RSA
RSA
FPRC/FPRR: PHARMA DYNAMICS (PTY) FPRC/FPRR: FPRR:
SANDOZ SA (PTY) LTD, SANDOZ SA (PTY) LTD,
LTD, SILVERWOOD CLOSE, SPARTAN, KEMPTON SPARTAN, KEMPTON PARK,
WESTLAKE, RSA PARK, RSA RSA
57
No. 36136
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58
MRF 15 MRF15 MRF 15

No. 36136
Name of medicine: SEROMIND 100 Name of medicine: Name of medicine:

RAN QUETIAPINE 200 SEROMIND 300
EQUIVALENT TO QUETIAPINE EQUIVALENT TO QUETIAPINE EQUIVALENT TO
100,0 mg 200,0 mg QUETIAPINE 300,0 mg
1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7, 8
Applicant: RANBAXY (SA) (PTY) LTD Applicant: RANBAXY (SA) (PTY) LTD Applicant: RANBAXY (SA) (PTY) LTD
Manufacturer: RANBAXY LABORATORIES Manufacturer. Manufacturer:
RANBAXY LABORATORIES RANBAXY LABORATORIES
LTD, PAONTA SAHIB, DIST. LTD, PAONTA SAHIB, DIST. LTD, PAONTA SAHIB, DIST.
SIRMOUR, HIMACHAL SIRMOUR, HIMACHAL SIRMOUR, HIMACHAL
PRADESH, INDIA PRADESH, INDIA PRADESH, INDIA
Packer: RANBAXY LABORATORIES Packer: Packer:
RANBAXY LABORATORIES RANBAXY LABORATORIES
Laboratory: FPRC: RANBAXY LABORATORIES Laboratory: FPRC: RANBAXY LABORATORIES Laboratory: FPRC RANBAXY LABORATORIES
LABORATORIES, ATLASVILLE, LABORATORIES, ATLASVILLE, LABORATORIES,
BOKSBURG, RSA BOKSBURG, RSA ATLASVILLE, BOKSBURG,
KHULULEKANI LABORATORY KHULULEKANI LABORATORY RSA
SERVICES, COVENTRY PARK, SERVICES, COVENTRY PARK, KHULULEKANI
MIDRAND, RSA
MIDRAND, RSA LABORATORY SERVICES,

COVENTRY PARK,
MIDRAND, RSA
FPRR: FPRR: FPRR:
RANBAXY (SA) (PTY) LTD, RANBAXY (SA) (PTY) LTD, RANBAXY (SA) (PTY) LTD,
CENTURION, RSA CENTURION, RSA CENTURION, RSA

MRF 15 MRF15 2F 15

Name of medicine: SEROMIND 25 Name of medicine: REFOBACIN PLUS BONE CEMENT 20 Name of medicine: RAN QUETIAPINE 300
Dosage form: TABLET Dosage form: BONE CEMENT Dosage form: TABLET
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH 22,4 g OF POWDER CONTAINS: Active ingredients: EACH TABLET CONTAINS:
QUETIAPINE FUMARATE GENTAMICIN SULPHATE EQUIVALENT TO QUETIAPINE FUMARATE EQUIVALENT
EQUIVALENT TO QUETIAPINE GENTAMICIN 0,3 g TO QUETIAPINE 300,0 mg
25,0 mg
Applicant: RANBAXY (SA) (PTY) LTD Applicant: MC PHARMA (PTY) LTD Applicant: RANBAXY (SA) (PTY) LTD
Manufacturer: RANBAXY LABORATORIES LTD, Manufacturer: aap BIOMATERIALS GmbH & CO. KG, Manufacturer: RANBAXY LABORATORIES LTD,
PAONTA SAHIB, DIST. SIRMOUR, DIEBURG, GERMANY PAONTA SAHIB, DIST. SIRMOUR,
HIMACHAL PRADESH, INDIA EMCM B.V, NIJMEGEN, THE HIMACHAL PRADESH, INDIA
NETHERLANDS
Packer: RANBAXY LABORATORIES LTD, Packer: aap BIOMATERIALS GmbH & CO. KG, Packer: RANBAXY LABORATORIES LTD,
PAONTA SAHIB, DIST. SIRMOUR, DIEBURG, GERMANY PAONTA SAHIB, DIST. SIRMOUR,
HIMACHAL PRADESH, INDIA EMCM B.V, NIJMEGEN, THE HIMACHAL PRADESH, INDIA
NETHERLANDS
BIOMET CEMENTING TECHNOLOGIES
AB, SJOBO, SWEDEN
aap BIOMATERIALS GmbH & CO. KG,
Laboratory: FPRC: RANBAXY LABORATORIES LTD, Laboratory: FPRC: DIEBURG, GERMANY Laboratory: FPRC RANBAXY LABORATORIES LTD,
PAONTA SAHIB, DIST. SIRMOUR, EMCM B.V, NIJMEGEN, THE PAONTA SAHIB, DIST. SIRMOUR,
HIMACHAL PRADESH, INDIA NETHERLANDS HIMACHAL PRADESH, INDIA
CONSULTING CHEMICAL BIOMET CEMENTING TECHNOLOGIES CONSULTING CHEMICAL
LABORATORIES, ATLASVILLE, AB, SJOBO, SWEDEN LABORATORIES, ATLASVILLE,
BOKSBURG, RSA BIOMET ORTHOPAEDICS SWITZERLAND, BOKSBURG, RSA
KHULULEKANI LABORATORY KEZERS, SWITZERLAND KHULULEKANI LABORATORY
SERVICES, COVENTRY PARK, ROSE MEDIZIN-UND SERVICES, COVENTRY PARK,
MIDRAND, RSA STERILISIERTECHNIK GmbH, TRIER, MIDRAND, RSA
GERMANY
STERIGENICS, ZOETERMEER, THE
NETHERLANDS
LABOR L&S AG, BAD BOCKLET-
GROSSENBRACH GERMANY
ACILAR AG, MORFELDEN-WALLDORF,
GERMANY
FARMALYSE BV, ZAANDAM, THE
NETHERLANDS
MAINSITE SERVICES GmbH & CO KG,

OBERNBURG, GERMANY
BACTIMM By, NIJMEGEN, THE
NETHERLANDS
FPRR: RANBAXY (SA) (PTY) LTD, FPRR: MC PHARMA (PTY) LTD, MNANDI, FPRC/FPRR: RANBAXY (SA) (PTY) LTD,
CENTURION, RSA WIERDAPARK, CENTURION, RSA CENTURION, RSA

No. 36136
0
59
60
MRF 15 MRF15 RF 15

Name of medicine: REFOBACIN PLUS BONE CEMENT 40 Name of medicine: REFOBACIN PLUS BONE CEMENT 60 Name of medicine: DIAMICRON MR 60 mg
Dosage form: BONE CEMENT Dosage form: BONE CEMENT Dosage form: MODIFIED RELEASE TABLET
No. 36136
Active ingredients: EACH 44,9 g OF POWDER CONTAINS: Active ingredients: EACH 67,4 g OF POWDER CONTAINS: Active ingredients: EACH TABLET CONTAINS:
GENTAMICIN SULPHATE EQUIVALENT GENTAMICIN SULPHATE EQUIVALENT GLICLAZIDE 60,0 mg
TO GENTAMICIN 0,6 g TO GENTAMICIN 0,8 g
Applicant: MC PHARMA (PTY) LTD Applicant: MC PHARMA (PTY) LTD Applicant: SERVIER LABORATORIES SA (PTY)
LTD
Manufacturer aap BIOMATERIALS GmbH & CO. KG, Manufacturer aap BIOMATERIALS GmbH & CO. KG, Manufacturer LES LABORATOIRES SERVIER
DIEBURG, GERMANY DIEBURG, GERMANY INDUSTRIE, GIDY, FRANCE
EMCM B.V, NIJMEGEN, THE EMCM B.V, NIJMEGEN, THE SERVIER (IRELAND) INDUSTRIES
NETHERLANDS NETHERLANDS LTD., ARKLOW, IRELAND
Packer: aap BIOMATERIALS GmbH &CO. KG, Packer: aap BIOMATERIALS GmbH & CO. KG, Packer: LES LABORATOIRES SERVIER
DIEBURG, GERMANY DIEBURG, GERMANY INDUSTRIE, GIDY, FRANCE
EMCM BM, NIJMEGEN, THE EMCM B.V, NIJMEGEN, THE SERVIER (IRELAND) INDUSTRIES
NETHERLANDS NETHERLANDS LTD., ARKLOW, IRELAND
BIOMET CEMENTING TECHNOLOGIES BIOMET CEMENTING TECHNOLOGIES MILLMOUNT HEALTHCARE LTD,
AB, SJOBO, SWEDEN AB, SJOBO, SWEDEN NAVAN, IRELAND
MILLMOUNT HEALTHCARE LTD,
DROGHEDA, IRELAND
aap BIOMATERIALS GmbH & CO. KG, aap BIOMATERIALS GmbH & CO. KG,
Laboratory: FPRC: DIEBURG, GERMANY Laboratory FPRC: DIEBURG, GERMANY Laboratory: FPRC LES LABORATOIRES SERVIER
EMCM B.V, NIJMEGEN, THE EMCM B.V, NIJMEGEN, THE INDUSTRIE, GIDIE, FRANCE
NETHERLANDS NETHERLANDS SERVIER (IRELAND) INDUSTRIES
BIOMET CEMENTING TECHNOLOGIES BIOMET CEMENTING TECHNOLOGIES LTD., ARKLOW, IRELAND
AB, SJOBO, SWEDEN AB, SJOBO, SWEDEN TECHNIKON LABORATORIES (PTY)
BIOMET ORTHOPAEDICS BIOMET ORTHOPAEDICS LTD, ROBERTVILLE, FLORIDA, RSA
SWITZERLAND, KEZERS, SWITZERLAND, KEZERS, SWITZERLAND M & L LABORATORY SERVICES
SWITZERLAND ROSE MEDIZIN-UND (PTY) LTD, LIMBRO BUSINESS
ROSE MEDIZIN-UND STERILISIERTECHNIK GmbH, TRIER, PARK, SANDTON, RSA
STERILISIERTECHNIK GmbH, TRIER, GERMANY
GERMANY STERIGENICS, ZOETERMEER, THE
STERIGENICS, ZOETERMEER, THE NETHERLANDS
NETHERLANDS LABOR L&S AG, BAD BOCKLET-
LABOR L&S AG, BAD BOCKLET- GROSSENBRACH GERMANY
GROSSENBRACH GERMANY ACILAR AG, MORFELDEN-WALLDORF,
ACILAR AG, MORFELDEN-WALLDORF, GERMANY
GERMANY FARMALYSE BV, ZAANDAM, THE

FARMALYSE BV, ZAANDAM, THE NETHERLANDS
NETHERLANDS MAINSITE SERVICES GmbH & CO KG,
MAINSITE SERVICES GmbH & CO KG, OBERNBURG, GERMANY
OBERNBURG, GERMANY BACTIMM BV, NIJMEGEN, THE
BACTIMM BV, NIJMEGEN, THE NETHERLANDS
NETHERLANDS
FPRC/FPRR: MC PHARMA (PTY) LTD, MNANDI, FPRC/FPRR: MC PHARMA (PTY) LTD, MNANDI, FPRR:: SERVIER LABORATORIES SA (PTY)
WIERDAPARK, CENTURION, RSA WIERDAPARK, CENTURION, RSA LTD, WOODMEAD, JOHANNESBURG,
RSA
Shelf-life: 24 months (Provisional) Shelf -life: 24 months (Provisional) Shelf-life: 24 months (Provisional)
MRF 15 MRF15 MRF 15

Name of medicine: GLUCTAM MR 60 mg Name of medicine: DIASTAL MR 60 mg Name of medicine: DIAGLUCIDE MR 60 mg
Dosage form: MODIFIED RELEASE TABLET Dosage form: MODIFIED RELEASE TABLET Dosage form: MODIFIED RELEASE TABLET
GLICLAZIDE 60,0 mg GLICLAZIDE 60,0 mg GLICLAZIDE 60,0 mg
registration:
Applicant: EGIS PHARMACEUTICALS SA (PTY) Applicant: BIOGARAN SA (PTY) LTD Applicant: BIOGARAN SA (PTY) LTD
LTD
Manufacturer: LES LABORATOIRES SERVIER Manufacturer: LES LABORATOIRES SERVIER Manufacturer: LES LABORATOIRES SERVIER
INDUSTRIE, GIDY, FRANCE INDUSTRIE, GIDY, FRANCE INDUSTRIE, GIDY, FRANCE
SERVIER (IRELAND) INDUSTRIES SERVIER (IRELAND) INDUSTRIES LTD., SERVIER (IRELAND) INDUSTRIES LTD.,
LTD., ARKLOW, IRELAND ARKLOW, IRELAND ARKLOW, IRELAND
Packer: LES LABORATOIRES SERVIER Packer: LES LABORATOIRES SERVIER Packer: LES LABORATOIRES SERVIER
INDUSTRIE, GIDY, FRANCE INDUSTRIE, GIDY, FRANCE INDUSTRIE, GIDY, FRANCE
MILLMOUNT HEALTHCARE LTD, MILLMOUNT HEALTHCARE LTD, MILLMOUNT HEALTHCARE LTD, NAVAN,
NAVAN, IRELAND NAVAN, IRELAND IRELAND
MILLMOUNT HEALTHCARE LTD, MILLMOUNT HEALTHCARE LTD, MILLMOUNT HEALTHCARE LTD,
DROGHEDA, IRELAND DROGHEDA, IRELAND DROGHEDA, IRELAND
TECHNIKON LABORATORIES (PTY) TECHNIKON LABORATORIES (PTY) TECHNIKON LABORATORIES (PTY) LTD,
LTD, ROBERTVILLE, FLORIDA, RSA LTD, ROBERTVILLE, FLORIDA, RSA ROBERTVILLE, FLORIDA, RSA
Laboratory: FPRC: LES LABORATOIRES SERVIER Laboratory: FPRC: LES LABORATOIRES SERVIER Laboratory: FPRC LES LABORATOIRES SERVIER
INDUSTRIE, GIDIE, FRANCE INDUSTRIE, GIDIE, FRANCE INDUSTRIE, GIDIE, FRANCE
TECHNIKON LABORATORIES (PTY) TECHNIKON LABORATORIES (PTY) TECHNIKON LABORATORIES (PTY) LTD,
LTD, ROBERTVILLE, FLORIDA, RSA LTD, ROBERTVILLE, FLORIDA, RSA ROBERTVILLE, FLORIDA, RSA
M & L LABORATORY SERVICES M & L LABORATORY SERVICES (PTY) M & L LABORATORY SERVICES (PTY)
(PTY) LTD, LIMBRO BUSINESS LTD, LIMBRO BUSINESS PARK, LTD, LIMBRO BUSINESS PARK,
PARK, SANDTON, RSA SANDTON, RSA SANDTON, RSA
FPRR: EGIS PHARMACEUTICALS SA (PTY) FPRC/FPRR: BIOGARAN SA (PTY) LTD, FPRR: BIOGARAN SA (PTY) LTD, WOODMEAD,
LTD, WOODMEAD, WOODMEAD, JOHANNESBURG, RSA JOHANNESBURG, RSA
JOHANNESBURG, RSA

No. 36136
61
62
MRF 15 MRF15 MRF 15
Name of medicine: ACCORD CISPLATIN 10 Name of medicine: ACCORD CISPLATIN 50 Name of medicine: PEXOLA ER 0,375 mg
Dosage form: INFUSION SOLUTION Dosage form: INFUSION SOLUTION Dosage form: TABLET
No. 36136
Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH TABLET CONTAINS
CISPLATIN 10,0 mg CISPLATIN 50,0 mg Pramipexole dihydrochloride
monohydrate equivalent to
Pramipexole 0,375 mg
Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7, 8
registration: registration: registration:
Applicant: ACCORD HEALTHCARE (PTY) Applicant: ACCORD HEALTHCARE Applicant: INGELHEIM
LTD (PTY) LTD PHARMACEUTICALS (PTY)
LTD
Manufacturer: INTAS PHARMACEUTICALS Manufacturer: INTAS PHARMACEUTICALS Manufacturer: BOEHRINGER INGELHEIM
LIMITED, VILLAGE MATODA, LIMITED, VILLAGE MATODA, PHARMA GmbH & Co. KG,
TALUKA, AHMEDABAD, TALUKA, AHMEDABAD, INGELHEIM am RHEIN,
GUJARAT, INDIA GUJARAT, INDIA GERMANY
Packer: INTAS PHARMACEUTICALS Packer: INTAS PHARMACEUTICALS Packer: BOEHRINGER INGELHEIM
Laboratory: FPRC: INTAS PHARMACEUTICALS Laboratory: FPRC: INTAS PHARMACEUTICALS Laboratory: FPRC BOEHRINGER INGELHEIM
CONSULTING CHEMICAL CONSULTING CHEMICAL PHAST GmbH,
LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD, HOMBURG/SAAR, GERMANY
PHARMASPEC CONSULTING RSA
LABORATORIES, FERNDALE, PHARMASPEC

LABORATORIES,
FERNDALE, RANDBURG,
RSA
FPRR: ACCORD HEALTHCARE (PTY) FPRR: ACCORD HEALTHCARE FPRR: INGELHEIM
LTD, RIVONIA, GAUTENG, RSA (PTY) LTD, RIVONIA, PHARMACEUTICALS (PTY)
GAUTENG, RSA LTD, FERNDALE, RANDBURG,
RSA
Name of medicine: PEXOLA ER 0,75 mg Name of medicine: PEXOLA ER 1,5 mg Name of medicine: PEXOLA ER 3,0 mg
Active ingredients: EACH TABLET CONTAINS Active ingredients: EACH TABLET CONTAINS Active ingredients: EACH TABLET CONTAINS
Pramipexole dihydrochloride Pramipexole dihydrochloride Pramipexole dihydrochloride
monohydrate equivalent to monohydrate equivalent to monohydrate eq u iva lent to
Pramipexole 0,75 mg Pramipexole 1,5 mg Pramipexole 3,0 mg
Applicant: INGELHEIM Applicant: INGELHEIM Applicant: INGELHEIM
PHARMACEUTICALS (PTY) LTD PHARMACEUTICALS (PTY) PHARMACEUTICALS (PTY)
LTD LTD
Manufacturer: BOEHRINGER INGELHEIM Manufacturer: BOEHRINGER INGELHEIM Manufacturer: BOEHRINGER INGELHEIM
PHARMA GmbH & Co. KG, PHARMA GmbH & Co. KG, PHARMA GmbH & Co. KG,
INGELHEIM am RHEIN, INGELHEIM am RHEIN, INGELHEIM am RHEIN,
GERMANY GERMANY GERMANY
Packer: BOEHRINGER INGELHEIM Packer: BOEHRINGER INGELHEIM Packer: BOEHRINGER INGELHEIM
PHARMA GmbH & Co. KG, PHARMA GmbH & Co. KG, PHARMA GmbH & Co. KG,
Laboratory: FPRC: BOEHRINGER INGELHEIM Laboratory: BOEHRINGER INGELHEIM Laboratory: FPRC BOEHRINGER INGELHEIM
PHARMA GmbH & Co. KG, FPRC: PHARMA GmbH & Co. KG, PHARMA GmbH & Co. KG,
PHAST GmbH, PHAST GmbH, PHAST GmbH,
HOMBURG/SAAR, GERMANY HOMBURG/SAAR, GERMANY HOMBURG/SAAR,

GERMANY
FPRR: INGELHEIM FPRR: INGELHEIM FPRR: INGELHEIM
PHARMACEUTICALS (PTY) PHARMACEUTICALS (PTY) PHARMACEUTICALS (PTY)
LTD, FERNDALE, RANDBURG, LTD, FERNDALE, RANDBURG, LTD, FERNDALE,
RSA RSA RANDBURG, RSA
No. 36136
63
64
MRF 15 MRF15 MRF 15
Registration number: 43/5.4.1/1066 Registration 44/15.2/0045 Registration number: 44/1.2/0114

number:
Name of medicine: PEXOLA ER 4,5 mg Name of medicine: OZURDEX Name of medicine: YELATE 30
No. 36136
Dosage form: TABLET Dosage form: INTRAVITREAL IMPLANT Dosage form: CAPSULE
Active ingredients: EACH TABLET CONTAINS Active ingredients: EACH IMPLANT CONTAINS: Active ingredients: EACH CAPSULE CONTAINS:
Pramipexole dihydrochloride DEXAMETHASONE 700,0 pg Duloxetine hydrochloride equivalent to
monohydrate equivalent to Duloxetine 30,0 mg
Pramipexole 4,5 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of 1, 2, 3, 4, 5, 6, 7, 8 Conditions of 1, 2, 3, 4, 5, 6, 7
Applicant: INGELHEIM PHARMACEUTICALS Applicant ALLERGAN PHARMACEUTICALS (PTY) Applicant: DR REDDY'S LABORATORIES (PTY)
(PTY) LTD LTD LTD
Manufacturer: BOEHRINGER INGELHEIM PHARMA Manufacturer: ALLERGAN PHARMACEUTICALS Manufacturer: DR REDDY'S LABORATORIES LIMITED,
GmbH & Co. KG, INGELHEIM am IRELAND, WESTPORT, COUNTY MAYO, QUTHUBULLAPUR MANDAL, RANGA
RHEIN, GERMANY IRELAND REDDY DISTRICT, ANDHRA PRADESH,
INDIA
Packer: BOEHRINGER INGELHEIM PHARMA Packer: ALLERGAN PHARMACEUTICALS Packer: DR REDDY'S LABORATORIES LIMITED,
INDIA
DRA PHARMACEUTICALS, IRENE,
CENTURION, RSA
PACKAGING (PTY) LTD, LONGDALE,
INDUSTRIA, RSA
Laboratory: FPRC: BOEHRINGER INGELHEIM PHARMA Laboratory: FPRC: ALLERGAN PHARMACEUTICALS Laboratory: FPRC DR REDDY'S LABORATORIES LIMITED,
PHAST GmbH, HOMBURG/SAAR, INSTITUTE FOR PHARMACEUTICAL INDIA
GERMANY SERVICES, SILVERTONDALE, INSTITUTE FOR PHARMACEUTICAL
PRETORIA, RSA SERVICES, SILVERTONDALE,
PRETORIA, RSA
WEST UNIVERSITY, POTCHEFSTROOM,
RSA
FPRR: INGELHEIM PHARMACEUTICALS FPRR: ALLERGAN PHARMACEUTICALS (PTY) FPRR: DR REDDY'S LABORATORIES (PTY)
(PTY) LTD, FENDALE, RANDBURG, LTD, RANDJESPARK EXT. 11, MIDRAND, LTD, THE PLACE, SANDTON, RSA
RSA RSA


Name of medicine: YELATE 60 Name of medicine: DRL DULOXETINE 30 Name of medicine: DRL DULOXETINE 60
Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH CAPSULE CONTAINS:
Duloxetine hydrochloride equivalent to Duloxetine hydrochloride equivalent Duloxetine hydrochloride
Duloxetine 60,0 mg to Duloxetine 30,0 mg equivalent to Duloxetine 60,0 mg
Applicant: DR REDDY'S LABORATORIES (PTY) Applicant: DR REDDY'S LABORATORIES Applicant: DR REDDY'S LABORATORIES
LTD (PTY) LTD (PTY) LTD
Manufacturer: DR REDDY'S LABORATORIES Manufacturer: DR REDDY'S LABORATORIES Manufacturer: DR REDDY'S LABORATORIES
LIMITED, QUTHUBULLAPUR LIMITED, QUTHUBULLAPUR LIMITED, QUTHUBULLAPUR
MANDAL, RANGA REDDY DISTRICT, MANDAL, RANGA REDDY MANDAL, RANGA REDDY
ANDHRA PRADESH, INDIA DISTRICT, ANDHRA PRADESH, DISTRICT, ANDHRA PRADESH,
INDIA INDIA
Packer: DR REDDY'S LABORATORIES Packer: DR REDDY'S LABORATORIES Packer: DR REDDY'S LABORATORIES
DRA PHARMACEUTICALS, IRENE, INDIA INDIA
CENTURION, RSA DRA PHARMACEUTICALS, IRENE, DRA PHARMACEUTICALS,
TECHNIKON LABORATORIES (PTY) CENTURION, RSA IRENE, CENTURION, RSA
LTD, ROBERTVILLE, FLORIDA, RSA TECHNIKON LABORATORIES TECHNIKON LABORATORIES
DIVPHARM MANUFACTURING AND (PTY) LTD, ROBERTVILLE, (PTY) LTD, ROBERTVILLE,
PACKAGING (PTY) LTD, FLORIDA, RSA FLORIDA, RSA
LONGDALE, INDUSTRIA, RSA DIVPHARM MANUFACTURING AND DIVPHARM MANUFACTURING
PACKAGING (PTY) LTD, AND PACKAGING (PTY) LTD,
LONGDALE, INDUSTRIA, RSA LONGDALE, INDUSTRIA, RSA
Laboratory: FPRC: DR REDDY'S LABORATORIES Laboratory: FPRC: DR REDDY'S LABORATORIES Laboratory: FPRC DR REDDY'S LABORATORIES
INSTITUTE FOR PHARMACEUTICAL INDIA INDIA
SERVICES, SILVERTONDALE, INSTITUTE FOR
INSTITUTE FOR
PRETORIA, RSA PHARMACEUTICAL SERVICES, PHARMACEUTICAL SERVICES,
RESEARCH INSTITUTE FOR SILVERTONDALE, PRETORIA, RSA SILVERTONDALE, PRETORIA,
INDUSTRIAL PHARMACY, NORTH- RESEARCH INSTITUTE FOR RSA
WEST UNIVERSITY, INDUSTRIAL PHARMACY, NORTH- RESEARCH INSTITUTE FOR
POTCHEFSTROOM, RSA WEST UNIVERSITY, INDUSTRIAL PHARMACY,
POTCHEFSTROOM, RSA NORTH-WEST UNIVERSITY,
POTCHEFSTROOM, RSA
FPRC DR REDDY'S LABORATORIES (PTY) FPRR: DR REDDY'S LABORATORIES FPRR: DR REDDY'S LABORATORIES
LTD, THE PLACE, SANDTON, RSA (PTY) LTD, THE PLACE, SANDTON, (PTY) LTD, THE PLACE,
RSA SANDTON, RSA

No. 36136
65
66
MRF 15 MRF15 F 15

Name of medicine: SPRYCEL 100 mg TABLETS Name of medicine: Name of medicine:
AXTERE 20 AXTERE 80
No. 36136
Dosage form: TABLET Dosage form: CONCENTRATE FOR SOLUTION Dosage form: CONCENTRATE FOR SOLUTION
FOR INFUSION FOR INFUSION
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS:
DASATINIB 100,0 mg DOCETAXEL 20,0 mg DOCETAXEL 80,0 mg
1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7, 8
registration:
Applicant: BRISTOL-MYERS SQUIBB (PTY) Applicant: ACCORD HEALTHCARE (PTY) LTD Applicant: ACCORD HEALTHCARE (PTY) LTD
LTD
Manufacturer: BRISTOL-MYERS SQUIBB Manufacturer: Manufacturer:
INTAS PHARMACEUTICALS INTAS PHARMACEUTICALS
COMPANY, MT VERNON, INDIANA, LIMITED, VILLAGE MATODA, LIMITED, VILLAGE MATODA,
USA TALUKA, AHMEDABAD, GUJARAT, TALUKA, AHMEDABAD, GUJARAT,
INDIA INDIA
Packer: BRISTOL-MYERS SQUIBB Packer. Packer:
INTAS PHARMACEUTICALS INTAS PHARMACEUTICALS
COMPANY, MT VERNON, INDIANA, LIMITED, VILLAGE MATODA, LIMITED, VILLAGE MATODA,
USA TALUKA, AHMEDABAD, GUJARAT, TALUKA, AHMEDABAD, GUJARAT,
BRISTOL-MYERS SQUIBB INDIA INDIA
COMPANY, EPERNON, FRANCE
BRISTOL-MYERS SQUIBB S.R.L,
ANAGNI, ITALY
Laboratory: FPRC: BRISTOL-MYERS SQUIBB Laboratory: FPRC: INTAS PHARMACEUTICALS Laboratory: FPRC INTAS PHARMACEUTICALS
COMPANY, EPERNON, FRANCE LIMITED, VILLAGE MATODA, LIMITED, VILLAGE MATODA,
BRISTOL-MYERS SQUIBB S.R.L, TALUKA, AHMEDABAD, GUJARAT, TALUKA, AHMEDABAD, GUJARAT,
ANAGNI, ITALY INDIA INDIA
LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD,
ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, RSA
NKUNZI PHARMACEUTICALS (PTY) PHARMASPEC CONSULTING PHARMASPEC CONSULTING
LTD, WADEVILLE, GERMISTON, LABORATORIES, FERNDALE, LABORATORIES, FERNDALE,

RSA RANDBURG, RSA RANDBURG, RSA
FPRR: BRISTOL-MYERS SQUIBB (PTY) FPRR: FPRR:
ACCORD HEALTHCARE (PTY) ACCORD HEALTHCARE (PTY) LTD,
LTD, BEDFORDVIEW, LTD, RIVONIA, GAUTENG, RSA RIVONIA, GAUTENG, RSA
JOHANNESBURG, RSA
MRF 15 MRF15 MRF 15

Name of medicine: ACCORD DOCETAXEL 20 Name of medicine: ACCORD DOCETAXEL 80 Name of medicine: ACCORD DOCETAXEL
DILUENT
Dosage form: CONCENTRATE FOR SOLUTION Dosage form: CONCENTRATE FOR Dosage form: SOLUTION FOR INJECTION
FOR INFUSION SOLUTION FOR INFUSION
Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS:
DOCETAXEL 20,0 mg DOCETAXEL 80,0 mg WATER FOR INJECTION
q.s 1,0 ml
POLYETHYLENE GLYCOL 400
130,0 mg
Applicant: ACCORD HEALTHCARE (PTY) Applicant: ACCORD HEALTHCARE Applicant: ACCORD HEALTHCARE (PTY)
LTD (PTY) LTD LTD
LIMITED, VILLAGE MATODA, LIMITED, VILLAGE MATODA, LIMITED, VILLAGE MATODA,
TALUKA, AHMEDABAD, GUJARAT, TALUKA, AHMEDABAD, TALUKA, AHMEDABAD,
INDIA GUJARAT, INDIA GUJARAT, INDIA
ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, ATLASVILLE, BOKSBURG, RSA
PHARMASPEC CONSULTING RSA PHARMASPEC CONSULTING

LABORATORIES, FERNDALE, PHARMASPEC LABORATORIES, FERNDALE,
RANDBURG, RSA CONSULTING RANDBURG, RSA
LABORATORIES,
FERNDALE, RANDBURG,
RSA
FPRR: ACCORD HEALTHCARE (PTY) FPRR: ACCORD HEALTHCARE FPRR: ACCORD HEALTHCARE (PTY)
LTD, RIVONIA, GAUTENG, RSA (PTY) LTD, RIVONIA, LTD, RIVONIA, GAUTENG, RSA
GAUTENG, RSA
No. 36136
67
68
MRF 15 MRF15 MRF 15
Registration number: 44/26/0729 Registration number: 44/1.2/0851 Registration number: 44/1.2/0852

Name of medicine: AXTERE DILUENT Name of medicine: ACCORD ESCITALOPRAM 10 Name of medicine: ACCORD ESCITALOPRAM 20
No. 36136
Dosage form: SOLUTION FOR INJECTION Dosage form: TABLET Dosage form: TABLET
Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS:
WATER FOR INJECTION ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE
q.s 1,0 ml EQUIVALENT TO EQUIVALENT TO
POLYETHYLENE GLYCOL 400 ESCITALOPRAM 10,0 mg ESCITALOPRAM 20,0 mg
130,0 mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of 1, 2, 3, 4, 5, 6, 7, 8
registration:
Applicant: ACCORD HEALTHCARE (PTY) Applicant ACCORD HEALTHCARE (PTY) Applicant: ACCORD HEALTHCARE (PTY)
LTD LTD LTD
TALUKA, AHMEDABAD, TALUKA, AHMEDABAD, TALUKA, AHMEDABAD,
GUJARAT, INDIA GUJARAT, INDIA GUJARAT, INDIA
ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, ATLASVILLE, BOKSBURG, RSA
PHARMASPEC CONSULTING RSA PHARMASPEC CONSULTING
LABORATORIES, FERNDALE, PHARMASPEC CONSULTING LABORATORIES, FERNDALE,
RANDBURG, RSA LABORATORIES, FERNDALE, RANDBURG, RSA

RANDBURG, RSA
FPRR: ACCORD HEALTHCARE (PTY) FPRR: ACCORD HEALTHCARE (PTY) FPRR: ACCORD HEALTHCARE (PTY)
LTD, RIVONIA, GAUTENG, RSA LTD, RIVONIA, GAUTENG, RSA LTD, RIVONIA, GAUTENG, RSA
Shelf-life: 24 months Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional)

MRF 15 MRF15 IF 15
Name of medicine: DIZOVIN 100 Name of medicine: Name of medicine:
DIZOVIN 300 NPLATE 250 pg
Dosage form: CAPSULE Dosage form: CAPSULE Dosage form: POWDER FOR SOLUTION
FOR INJECTION
Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH 0,5 ml SOLUTION
ZIDOVUDINE 100,0 mg ZIDOVUDINE 300,0 mg CONTAINS:
ROMIPLOSTIM 250,0 pg
1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7
Applicant: MACLEODS PHARMACEUTICALS Applicant MACLEODS Applicant: BATSWADI
SA (PTY) LTD PHARMACEUTICALS SA (PTY) PHARMACEUTICALS (PTY)
LTD LTD
Manufacturer: MACLEODS PHARMACEUTICALS Manufacturer: Manufacturer:
MACLEODS PATHEON S.p.A, MONZA,
LTD, KACHIGAM, DAMAN, INDIA PHARMACEUTICALS LTD, ITALY
KACHIGAM, DAMAN, INDIA
Packer: MACLEODS PHARMACEUTICALS Packer: Packer:
MACLEODS AMGEN EUROPE BV (ABR),
LTD, KACHIGAM, DAMAN, INDIA PHARMACEUTICALS LTD, BREDA, THE
KACHIGAM, DAMAN, INDIA NETHERLANDS
Laboratory: FPRC: MACLEODS PHARMACEUTICALS Laboratory: FPRC: MACLEODS Laboratory: FPRC AMGEN EUROPE BV (ABR),
LTD, KACHIGAM, DAMAN, INDIA PHARMACEUTICALS LTD, BREDA, THE
CONSULTING CHEMICAL KACHIGAM, DAMAN, INDIA NETHERLANDS
LABORATORIES, ATLASVILLE, CONSULTING CHEMICAL
BOKSBURG, RSA LABORATORIES, ATLASVILLE,
SEDEK AGRICHEM, DEGRAS BOKSBURG, RSA
ROAD, SILVERTON, PRETORIA, SEDEK AGRICHEM, DEGRAS
RSA ROAD, SILVERTON,
PRETORIA, RSA
FPRR: MACLEODS PHARMACEUTICALS FPRR: FPRR:

MACLEODS BATSWADI
SA (PTY) LTD, HALFWAY HOUSE, PHARMACEUTICALS SA (PTY) PHARMACEUTICALS (PTY)
MIDRAND, RSA LTD, HALFWAY HOUSE, LTD, PETER PLACE,
MIDRAND, RSA BRYANSTON, RSA
No. 36136
69
70
MRF 15 MRF15 IF 15

Name of medicine: NPLATE 500 pg Name of medicine: Name of medicine:
SIZONORM 25 mg SIZONORM 100 mg
Dosage form: POWDER FOR SOLUTION FOR Dosage form: TABLET Dosage form: TABLET
No. 36136
INJECTION
Active ingredients: EACH 1,0 ml SOLUTION Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS:
CONTAINS: QUETIAPINE FUMARATE QUETIAPINE FUMARATE
ROMIPLOSTIM 500,0 pg EQUIVALENT TO QUETIAPINE EQUIVALENT TO
25,0 mg QUETIAPINE 100,0 mg
1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7, 8 1, 2, 3, 4, 5, 6, 7, 8
Applicant: BATSWADI Applicant: SUN PHARMACEUTICALS SA Applicant: SUN PHARMACEUTICALS
PHARMACEUTICALS (PTY) LTD (PTY) LTD SA (PTY) LTD
Manufacturer. Manufacturer: Manufacturer:
PATHEON S.p.A, MONZA, ITALY SUN PHARMACEUTICALS SUN PHARMACEUTICALS
INDUSTRIES LIMITED, DADRA INDUSTRIES LIMITED,
& NAGAR HAVELI, INDIA DADRA & NAGAR HAVELI,
INDIA
Packer: AMGEN EUROPE BV (ABR), Packer Packer
SUN PHARMACEUTICALS SUN PHARMACEUTICALS
BREDA, THE NETHERLANDS INDUSTRIES LIMITED, DADRA INDUSTRIES LIMITED,
INDIA
Laboratory: FPRC: AMGEN EUROPE BV (ABR), Labdratory: FPRC: SUN PHARMACEUTICALS Laboratory: FPRC SUN PHARMACEUTICALS
BREDA, THE NETHERLANDS INDUSTRIES LIMITED, DADRA INDUSTRIES LIMITED,
CONSULTING CHEMICAL INDIA
LABORATORIES, ATLASVILLE, CONSULTING CHEMICAL
BOKSBURG, RSA LABORATORIES,
RESEARCH INSTITUTE FOR ATLASVILLE, BOKSBURG,
INDUSTRIAL PHARMACY, RSA
NORTH WEST UNIVERSITY, RESEARCH INSTITUTE
POTCHEFSTROOM, RSA FOR INDUSTRIAL
PHARMACY, NORTH WEST

UNIVERSITY,
POTCHEFSTROOM, RSA
FPRR: BATSWADI FPRR: FPRR:
SUN PHARMACEUTICALS SA SUN PHARMACEUTICALS
PHARMACEUTICALS (PTY) (PTY) LTD, MIDRAND, RSA SA (PTY) LTD, MIDRAND,
LTD, PETER PLACE, RSA
BRYANSTON, RSA
MRF 15 MRF15 MRF 15
Name of medicine: SIZONORM 200 mg Name of medicine: SIZONORM 300 mg Name of medicine: VIRAMUNE XR 50 mg
Dosage form: TABLET Dosage form: TABLET Dosage form: MODIFIED RELEASE TABLET
QUETIAPINE FUMARATE QUETIAPINE FUMARATE NEVIRAPINE (ANHYDROUS)
EQUIVALENT TO QUETIAPINE EQUIVALENT TO QUETIAPINE 50 mg
200,0 mg 300,0 mg
Applicant: SUN PHARMACEUTICALS SA (PTY) Applicant: SUN PHARMACEUTICALS SA (PTY) Applicant: INGELHEIM
LTD LTD PHARMACEUTICALS (PTY) LTD
Manufacturer: SUN PHARMACEUTICALS Manufacturer: SUN PHARMACEUTICALS Manufacturer: BOEHRINGER INGELHEIM
INDUSTRIES LIMITED, DADRA & INDUSTRIES LIMITED, DADRA & ROXANE INC, WILSON ROAD,
NAGAR HAVELI, INDIA NAGAR HAVELI, INDIA COLUMBUS, OHIO, USA
Packer: SUN PHARMACEUTICALS Packer: SUN PHARMACEUTICALS Packer: BOEHRINGER INGELHEIM
INDUSTRIES LIMITED, DADRA & INDUSTRIES LIMITED, DADRA & ROXANE INC, WILSON ROAD,
SIXARP, LLC - PRAXIS
PACKAGING SOLUTIONS,
GRAND RAPIDS, MICHIGAN,
USA
SIXARP, LLC - PRAXIS
PACKAGING SOLUTIONS,
COLUMBUS, OHIO, USA
DRA PHARMACEUTICALS,
IRENE, PRETORIA, RSA
Laboratory: FPRC: SUN PHARMACEUTICALS Laboratory: SUN PHARMACEUTICALS Laboratory: FPRC BOEHRINGER INGELHEIM
INDUSTRIES LIMITED, DADRA & FPRC: INDUSTRIES LIMITED, DADRA & ROXANE INC., WILSON RD,
CONSULTING CHEMICAL CONSULTING CHEMICAL BOEHRINGER INGELHEIM
LABORATORIES, ATLASVILLE, LABORATORIES, ATLASVILLE, ROXANE INC., OAK STREET,
BOKSBURG, RSA BOKSBURG, RSA COLUMBUS, OHIO, USA
RESEARCH INSTITUTE FOR RESEARCH INSTITUTE FOR RESEARCH INSTITUTE FOR
INDUSTRIAL PHARMACY, NORTH INDUSTRIAL PHARMACY, NORTH INDUSTRIAL PHARMACY,

WEST UNIVERSITY, WEST UNIVERSITY, NORTH WEST UNIVERSITY,
POTCHEFSTROOM, RSA POTCHEFSTROOM, RSA POTCHEFSTROOM, RSA
WINTHROP
PHARMACEUTICALS (PTY)
LTD, WALTLOO, PRETORIA,
RSA
FPRR: SUN PHARMACEUTICALS SA (PTY) FPRR: SUN PHARMACEUTICALS SA (PTY) FPRR: INGELHEIM
LTD, MIDRAND, RSA LTD, MIDRAND, RSA PHARMACEUTICALS (PTY)
LTD, FERNDALE, RANDBURG,
RSA
No. 36136
71
72
MRF 15 MRF15 MRF 15

Name of medicine: VIRAMUNE XR 100 mg Name of medicine: VIRAMUNE XR 400 mg Name of medicine: ALVIR XR 50 mg
No. 36136
NEVIRAPINE (ANHYDROUS) 100 mg NEVIRAPINE (ANHYDROUS) NEVIRAPINE (ANHYDROUS)
400 mg 50 mg
Applicant INGELHEIM PHARMACEUTICALS Applicant: INGELHEIM PHARMACEUTICALS Applicant: INGELHEIM
(PTY) LTD (PTY) LTD PHARMACEUTICALS (PTY) LTD
Manufacturer: BOEHRINGER INGELHEIM ROXANE Manufacturer: BOEHRINGER INGELHEIM Manufacturer: BOEHRINGER INGELHEIM
INC, WILSON ROAD, COLUMBUS, ROXANE INC, WILSON ROAD, ROXANE INC, WILSON ROAD,
OHIO, USA COLUMBUS, OHIO, USA COLUMBUS, OHIO, USA
Packer: BOEHRINGER INGELHEIM ROXANE Packer: BOEHRINGER INGELHEIM Packer: BOEHRINGER INGELHEIM
INC, WILSON ROAD, COLUMBUS, ROXANE INC, WILSON ROAD, ROXANE INC, WILSON ROAD,
SIXARP, LLC - PRAXIS PACKAGING SIXARP, LLC - PRAXIS SIXARP, LLC - PRAXIS
SOLUTIONS, GRAND RAPIDS, PACKAGING SOLUTIONS, GRAND PACKAGING SOLUTIONS,
MICHIGAN, USA RAPIDS, MICHIGAN, USA GRAND RAPIDS, MICHIGAN,
SIXARP, LLC - PRAXIS PACKAGING SIXARP, LLC - PRAXIS USA
SOLUTIONS, COLUMBUS, OHIO, PACKAGING SOLUTIONS, SIXARP, LLC - PRAXIS
USA COLUMBUS, OHIO, USA PACKAGING SOLUTIONS,
DRA PHARMACEUTICALS, IRENE, DRA PHARMACEUTICALS, IRENE, COLUMBUS, OHIO, USA
PRETORIA, RSA PRETORIA, RSA DRA PHARMACEUTICALS,
IRENE, PRETORIA, RSA
Laboratory: FPRC: BOEHRINGER INGELHEIM ROXANE Laboratory: FPRC: BOEHRINGER INGELHEIM Laboratory: FPRC BOEHRINGER INGELHEIM
INC., WILSON ROAD, COLUMBUS, ROXANE INC., WILSON ROAD, ROXANE INC., WILSON ROAD,
BOEHRINGER INGELHEIM ROXANE BOEHRINGER INGELHEIM BOEHRINGER INGELHEIM
INC., OAK STREET, COLUMBUS, ROXANE INC., OAK STREET, ROXANE INC., OAK STREET,
INDUSTRIAL PHARMACY, NORTH INDUSTRIAL PHARMACY, NORTH INDUSTRIAL PHARMACY,
WEST UNIVERSITY, WEST UNIVERSITY, NORTH WEST UNIVERSITY,
WINTHROP PHARMACEUTICALS WINTHROP PHARMACEUTICALS WINTHROP

(PTY) LTD, WALTLOO, PRETORIA, (PTY) LTD, WALTLOO, PRETORIA, PHARMACEUTICALS (PTY)
RSA RSA LTD, WALTLOO, PRETORIA,
RSA
FPRR: INGELHEIM PHARMACEUTICALS FPRR: INGELHEIM PHARMACEUTICALS FPRR: INGELHEIM
(PTY) LTD, FERNDALE, RANDBURG, (PTY) LTD, FERNDALE, PHARMACEUTICALS (PTY)
RSA RANDBURG, RSA LTD, FERNDALE, RANDBURG,
RSA
Shelf-life: 24 months Shelf -life: 24 months Shelf-life: 24 months
MRF 15 MRF15 MRF 15
Name of medicine: ALVIR XR 100 mg Name of medicine: ALVIR XR 400 mg Name of medicine: NEVIRAPINE XR IP 50 mg
NEVIRAPINE (ANHYDROUS) 100 mg NEVIRAPINE (ANHYDROUS) NEVIRAPINE (ANHYDROUS) 50 mg
400 mg
Applicant INGELHEIM PHARMACEUTICALS Applicant: INGELHEIM PHARMACEUTICALS Applicant: INGELHEIM PHARMACEUTICALS
(PTY) LTD (PTY) LTD (PTY) LTD
Manufacturer: BOEHRINGER INGELHEIM ROXANE Manufacturer: BOEHRINGER INGELHEIM Manufacturer: BOEHRINGER INGELHEIM ROXANE
INC, WILSON ROAD, COLUMBUS, ROXANE INC, WILSON ROAD, INC, WILSON ROAD, COLUMBUS,
OHIO, USA COLUMBUS, OHIO, USA OHIO, USA
Packer: BOEHRINGER INGELHEIM ROXANE Packer: BOEHRINGER INGELHEIM Packer: BOEHRINGER INGELHEIM ROXANE
INC, WILSON ROAD, COLUMBUS, ROXANE INC, WILSON ROAD, INC, WILSON ROAD, COLUMBUS,
SIXARP, LLC - PRAXIS PACKAGING SIXARP, LLC - PRAXIS SIXARP, LLC - PRAXIS PACKAGING
SOLUTIONS, GRAND RAPIDS, PACKAGING SOLUTIONS, GRAND SOLUTIONS, GRAND RAPIDS,
MICHIGAN, USA RAPIDS, MICHIGAN, USA MICHIGAN, USA
SIXARP, LLC - PRAXIS PACKAGING SIXARP, LLC - PRAXIS SIXARP, LLC - PRAXIS PACKAGING
SOLUTIONS, COLUMBUS, OHIO, PACKAGING SOLUTIONS, SOLUTIONS, COLUMBUS, OHIO,
USA COLUMBUS, OHIO, USA USA
DRA PHARMACEUTICALS, IRENE, DRA PHARMACEUTICALS, IRENE, DRA PHARMACEUTICALS, IRENE,
PRETORIA, RSA PRETORIA, RSA PRETORIA, RSA
Laboratory: FPRC: BOEHRINGER INGELHEIM ROXANE Laboratory. FPRC: BOEHRINGER INGELHEIM Laboratory: FPRC BOEHRINGER INGELHEIM ROXANE
INC., WILSON ROAD, COLUMBUS, ROXANE INC., WILSON ROAD, INC., WILSON ROAD, COLUMBUS,
BOEHRINGER INGELHEIM ROXANE BOEHRINGER INGELHEIM BOEHRINGER INGELHEIM ROXANE
INC., OAK STREET, COLUMBUS, ROXANE INC., OAK STREET, INC., OAK STREET, COLUMBUS,
INDUSTRIAL PHARMACY, NORTH INDUSTRIAL PHARMACY, NORTH INDUSTRIAL PHARMACY, NORTH
WEST UNIVERSITY, WEST UNIVERSITY, WEST UNIVERSITY,

WINTHROP PHARMACEUTICALS WINTHROP PHARMACEUTICALS WINTHROP PHARMACEUTICALS
(PTY) LTD, WALTLOO, PRETORIA, (PTY) LTD, WALTLOO, PRETORIA, (PTY) LTD, WALTLOO, PRETORIA,
RSA RSA RSA
FPRR: INGELHEIM PHARMACEUTICALS FPRR: INGELHEIM PHARMACEUTICALS FPRR: INGELHEIM PHARMACEUTICALS
(PTY) LTD, FERNDALE, RANDBURG, (PTY) LTD, FERNDALE, (PTY) LTD, FERNDALE,
RSA RANDBURG, RSA RANDBURG, RSA

No. 36136
73
74
MRF 15 MRF15 MRF 15

Name of medicine: NEVIRAPINE XR IP 100 mg Name of medicine: NEVIRAPINE XR IP 400 mg Name of medicine: RICOVIR
No. 36136
Dosage form: MODIFIED RELEASE TABLET Dosage form: MODIFIED RELEASE TABLET Dosage form: TABLET
NEVIRAPINE (ANHYDROUS) 100 mg NEVIRAPINE (ANHYDROUS) 400 mg Tenofovir disoproxil fumarate
300,0mg
Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7
Applicant: INGELHEIM PHARMACEUTICALS (PTY) Applicant INGELHEIM PHARMACEUTICALS (PTY) Applicant: MYLAN (PTY) LTD
LTD LTD
Manufacturer: BOEHRINGER INGELHEIM ROXANE Manufacturer: BOEHRINGER INGELHEIM ROXANE Manufacturer: MATRIX LABORATORIES LIMITED,
INC, WILSON ROAD, COLUMBUS, INC, WILSON ROAD, COLUMBUS, SINNAR,NASHIK, MAHARASHTRA,
OHIO, USA OHIO, USA INDIA
Packer: BOEHRINGER INGELHEIM ROXANE Packer: BOEHRINGER INGELHEIM ROXANE Packer: MATRIX LABORATORIES LIMITED,
INC, WILSON ROAD, COLUMBUS, INC, WILSON ROAD, COLUMBUS, S I NNAR, NASHIK, MAHARASHTRA,
SIXARP, LLC - PRAXIS PACKAGING SIXARP, LLC - PRAXIS PACKAGING
SOLUTIONS, GRAND RAPIDS, SOLUTIONS, GRAND RAPIDS,
MICHIGAN, USA MICHIGAN, USA
SIXARP, LLC - PRAXIS PACKAGING SIXARP, LLC - PRAXIS PACKAGING
SOLUTIONS, COLUMBUS, OHIO, USA SOLUTIONS, COLUMBUS, OHIO, USA
DRA PHARMACEUTICALS, IRENE, DRA IRENE,
PRETORIA, RSA PRETORIA, RSA
Laboratory: FPRC: BOEHRINGER INGELHEIM ROXANE Laboratory: FPRC: BOEHRINGER INGELHEIM ROXANE Laboratory: FPRC MATRIX LABORATORIES LIMITED,
INC., WILSON ROAD, COLUMBUS, INC., WILSON ROAD, COLUMBUS, SINNAR,NASHIK, MAHARASHTRA,
BOEHRINGER INGELHEIM ROXANE BOEHRINGER INGELHEIM ROXANE
INC., OAK STREET, COLUMBUS, OHIO, ,
CONSULTING CHEMICAL
INC OAK STREET, COLUMBUS, OHIO,
USA USA LABORATORIES, ATLASVILLE,
RESEARCH INSTITUTE FOR RESEARCH INSTITUTE FOR BOKSBURG, RSA
INDUSTRIAL PHARMACY, NORTH INDUSTRIAL PHARMACY, NORTH ACORN PHARMACEUTICALS (PTY)
WEST UNIVERSITY, WEST UNIVERSITY, LTD, NORTH RIDING,
POTCHEFSTROOM, RSA POTCHEFSTROOM, RSA JOHANNESBURG, RSA

WINTHROP PHARMACEUTICALS (PTY) WINTHROP PHARMACEUTICALS (PTY)
PHARMASPEC CONSULTING
LTD, WALTLOO, PRETORIA, RSA LTD, PRETORIA, RSA
RANDBURG, RSA
FPRR: INGELHEIM PHARMACEUTICALS (PTY) FPRR: INGELHEIM PHARMACEUTICALS (PTY) FPRR: MYLAN (PTY) LTD,
LTD, FERNDALE, RANDBURG, RSA LTD, FERNDALE, RANDBURG, RSA MODDERFONTEIN,
JOHANNESBURG, RSA
MRF 15 MRF15 MRF 15

Name of medicine: MACLEODS NEVIRAPINE 200 mg Name of medicine: EFAMAT 50 mg Name of medicine: EFAMAT 100 mg
NEVIRAPINE 200,0 mg EFAVIRENZ 50,0 mg EFAVIRENZ 100,0 mg
Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7
Applicant: MACLEODS PHARMACEUTICALS Applicant: MYLAN (PTY) LTD Applicant: MYLAN (PTY) LTD
SA (PTY) LTD
Manufacturer: MACLEODS PHARMACEUTICALS Manufacturer: MATRIX LABORATORIES Manufacturer: MATRIX LABORATORIES

LTD, KACHIGAM, DAMAN, INDIA LIMITED, SINNAR,NASHIK, LIMITED, SINNAR,NASHIK,
MAHARASHTRA, INDIA MAHARASHTRA, INDIA
Packer: MACLEODS PHARMACEUTICALS Packer: MATRIX LABORATORIES Packer: MATRIX LABORATORIES
LTD, KACHIGAM, DAMAN, INDIA LIMITED, SINNAR,NASHIK, LIMITED, SINNAR,NASHIK,
Laboratory: FPRC: MACLEODS PHARMACEUTICALS Laboratory: FPRC: MATRIX LABORATORIES Laboratory: FPRC MATRIX LABORATORIES
LTD, KACHIGAM, DAMAN, INDIA LIMITED, SINNAR,NASHIK,
CONSULTING CHEMICAL LIMITED, SINNAR,NASHIK,
LABORATORIES ((TY) LTD,
ATLASVILLE, BOKSBURG, RSA CONSULTING CHEMICAL CONSULTING CHEMICAL
SEDEK AGRICHEM, DEGRAS LABORATORIES, ATLASVILLE, LABORATORIES,
ROAD, SILVERTON, PRETORIA, BOKSBURG, RSA ATLASVILLE, BOKSBURG,
RSA ACORN PHARMACEUTICALS RSA
(PTY) LTD, NORTH RIDING, ACORN
JOHANNESBURG, RSA PHARMACEUTICALS (PTY)
PHARMASPEC CONSULTING LTD, NORTH RIDING,
LABORATORIES, FERNDALE, JOHANNESBURG, RSA
RANDBURG, RSA PHARMASPEC
CONSULTING
LABORATORIES,
FERNDALE, RANDBURG,
RSA
FPRR: MACLEODS PHARMACEUTICALS FPRR: FPRR:
MYLAN (PTY) LTD, MYLAN (PTY) LTD,
SA (PTY) LTD, HALFWAY HOUSE, MODDERFONTEIN,
MIDRAND, RSA
MODDERFONTEIN,
JOHANNESBURG, RSA JOHANNESBURG, RSA
Shelf-life: 24 months (Provisional) Shelf-life: 24 months Shelf-life: 24 months
Date of registration: 07 DECEMBER 2012 Date of registration: 07 DECENBER 2012 Date of registration: 07 DECENBER 2012
No. 36136
75
76
MRF 15 MRF15 MRF 15
Registration number: 46/20.2.8/0022 Registration number: 46/26/0866 Registration number: 46/32.4/0867

Name of medicine: EFAMAT 200 mg Name of medicine: HERCLON Name of medicine: HERCLON BWFI
Dosage form: TABLET Dosage form: POWDER FOR SOLUTION FOR Dosage form: DILUENT FOR INJECTION
No. 36136
INFUSION
Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS:
EFAVIRENZ 200,0 mg TRASTUZUMAB 440,0 mg Bacteriostatic water for injection
20,0 ml
Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7
registration:
Applicant: MYLAN (PTY) LTD Applicant ROCHE PRODUCTS (PTY) LTD Applicant: ROCHE PRODUCTS (PTY) LTD
Manufacturer: MATRIX LABORATORIES LIMITED, Manufacturer: GENENTECH INC., SOUTH SAN Manufacturer: F. HOFFMANN-LA ROCHE LTD,
SINNAR,NASHIK, MAHARASHTRA, FRANCISCO, CALIFORNIA, USA KAISERAUGST SWITZERLAND
INDIA GENENTECH INC., VACAVILLE, F. HOFFMANN-LA ROCHE LTD,
CALIFORNIA, USA BASEL, SWITZERLAND
Packer: MATRIX LABORATORIES LIMITED, Packer: GENENTECH INC., SOUTH SAN Packer: F. HOFFMANN-LA ROCHE LTD,
INDIA GENENTECH INC., VACAVILLE, F. HOFFMANN-LA ROCHE LTD,
CALIFORNIA, USA BASEL, SWITZERLAND
F. HOFFMANN-LA ROCHE LTD, GP GRENZACH
KAISERAUGST SWITZERLAND PRODUCTIONS, GRENZACH-
AKACIA HEALTH CARE (PTY) LTD, WYHLEN, SWITZERLAND
ISANDO, JOHANNESBURG, RSA AKACIA HEALTH CARE (PTY)
LTD, ISANDO,
JOHANNESBURG, RSA
Laboratory: FPRC: MATRIX LABORATORIES LIMITED, Laboratory: FPRC: GENENTECH INC., SOUTH SAN Laboratory: FPRC F. HOFFMANN-LA ROCHE LTD,
INDIA F. HOFFMANN-LA ROCHE LTD, F. HOFFMANN-LA ROCHE LTD,
CONSULTING CHEMICAL KAISERAUGST SWITZERLAND BASEL, SWITZERLAND
LABORATORIES, ATLASVILLE, F. HOFFMANN-LA ROCHE LTD, AKACIA HEALTH CARE (PTY)
BOKSBURG, RSA BASEL, SWITZERLAND LTD, ISANDO,
ACORN PHARMACEUTICALS (PTY) AKACIA HEALTH CARE (PTY) LTD, JOHANNESBURG, RSA
LTD, NORTH RIDING, ISANDO, JOHANNESBURG, RSA
JOHANNESBURG, RSA
PHARMASPEC CONSULTING
RANDBURG, RSA
FPRR: MYLAN (PTY) LTD, MODDERFONTEIN, FPRR: ROCHE PRODUCTS (PTY) LTD, FPRR: ROCHE PRODUCTS (PTY) LTD,
JOHANNESBURG, RSA ILLOVO, JOHANNESBURG, RSA ILLOVO, JOHANNESBURG, RSA

Date of registration: 07 DECENBER 2012 Date of registration: 07 DECEMBER 2012 Date of registration: 07 DECEMBER 2012
MRF 15 MRF15 2F 15

Name of medicine: RISTOVA 100 Name of medicine: RISTOVA 500 Name of medicine: MACLEODS EMTRICITABINE AND
TENOFOVIR 200 mg/300 mg
Dosage form: SOLUTION FOR INFUSION Dosage form: SOLUTION FOR INFUSION Dosage form: TABLET
Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH TABLET CONTAINS:
RITUXIMAB 100,0 mg RITUXIMAB 500,0 mg EMTRICITABINE 200,0 mg
TENOFOVIR DISOPROXIL FUMARATE
300,0
Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8
Applicant: ROCHE PRODUCTS (PTY) LTD Applicant: ROCHE PRODUCTS (PTY) LTD Applicant: MACLEODS PHARMACEUTICALS SA
(PTY) LTD
Manufacturer: GENENTECH INC., SOUTH SAN Manufacturer: GENENTECH INC., SOUTH SAN Manufacturer: MACLEODS PHARMACEUTICALS
FRANCISCO, CALIFORNIA, USA FRANCISCO, CALIFORNIA, USA LIMITED, KACHIGAM, DAMAN, INDIA
F. HOFFMANN-LA ROCHE LTD, BASEL, F. HOFFMANN-LA ROCHE LTD, BASEL, MACLEODS PHARMACEUTICALS LTD,
SWITZERLAND SWITZERLAND TEHSIL NALAGARH, DISTRICT SOLAN,
ROCHE DIAGNOSTICS GmbH, ROCHE DIAGNOSTICS GmbH, HIMACHAL PRADESH, INDIA
MANNHEIM, GERMANY MANNHEIM, GERMANY
Packer GENENTECH INC., SOUTH SAN Packer: GENENTECH INC., SOUTH SAN Packer: MACLEODS PHARMACEUTICALS
F. HOFFMANN-LA ROCHE LTD, F. HOFFMANN-LA ROCHE LTD, MACLEODS PHARMACEUTICALS LTD,
KAISERAUGST SWITZERLAND KAISERAUGST SWITZERLAND TEHSIL NALAGARH, DISTRICT SOLAN,
F. HOFFMANN-LA ROCHE LTD, BASEL, F. HOFFMANN-LA ROCHE LTD, BASEL, HIMACHAL PRADESH, INDIA
ROCHE DIAGNOSTICS GmbH, ROCHE DIAGNOSTICS GmbH,
MANNHEIM, GERMANY MANNHEIM, GERMANY
AKACIA HEALTH CARE (PTY) LTD, AKACIA HEALTH CARE (PTY) LTD,
ISANDO, JOHANNESBURG, RSA ISANDO, JOHANNESBURG, RSA
Laboratory: FPRC: GENENTECH INC , SOUTH SAN Laboratory: FPRC: GENENTECH INC., SOUTH SAN Laboratory: FPRC MACLEODS PHARMACEUTICALS
ROCHE DIAGNOSTICS GmbH, ROCHE DIAGNOSTICS GmbH, MACLEODS PHARMACEUTICALS LTD,
MANNHEIM, GERMANY MANNHEIM, GERMANY TEHSIL NALAGARH, DISTRICT SOLAN,
F. HOFFMANN-LA ROCHE LTD, F. HOFFMANN-LA ROCHE LTD, HIMACHAL PRADESH, INDIA
KAISERAUGST SWITZERLAND KAISERAUGST SWITZERLAND CONSULTING CHEMICAL
F. HOFFMANN-LA ROCHE LTD, BASEL, F. HOFFMANN-LA ROCHE LTD, BASEL, LABORATORIES, ATLASVILLE,
SWITZERLAND SWITZERLAND BOKSBURG, RSA
AKACIA HEALTH CARE (PTY) LTD, AKACIA HEALTH CARE (PTY) LTD, SEDEK AGRICHEM, DEGRAS ROAD,
ISANDO, JOHANNESBURG, RSA ISANDO, JOHANNESBURG, RSA SILVERTONDALE, PRETORIA, RSA
KHULULEKANI LABORATORY SERVICES
CC, COVENTRY PARK MIDRAND, RSA
FPRR: ROCHE PRODUCTS (PTY) LTD, ILLOVO, FPRR: FPRR:
ROCHE PRODUCTS (PTY) LTD, ILLOVO, MACLEODS PHARMACEUTICALS SA
JOHANNESBURG, RSA JOHANNESBURG, RSA (PTY) LTD, HALFWAY HOUSE, MIDRAND,
RSA

No. 36136
77

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STAATSKOERANT, 6 FEBRUARIE 2013 No.

MEDICINES CONTROL COUNCIL

Registration number: 07/13.3.1/24 Registration number: A39/20.2.2/0589 Registration number: A39/7.1/0590

PHARMA-Q, INDUSTRIA WEST, ASPEN PHARMACARE EAST LONDON,

Registration number: A40/11.4.3/0153 Registration number: 41/3.1/0252 Registration number: 41/3.1/0253

Shelf-life: 24 months Date of registration: Date of registration:

Date of registration: 26 OCTOBER 2012

Registration 41/7.1.3/0770 Registration number: 41/7.1.3/0771 Registration number: 42/8.2/0193

(PTY) LTD, LIMBRO BUSINESS (PTY) LTD, LIMBRO BUSINESS

Shelf-life: 24 months Shelf-life: 24 months FPRR: SANOFI-AVENTIS S.A., MIDRAND, RSA

Date of registration 26 OCTOBER 2012

MRF 15 MRF15 V1RF 15

Registration 42/8.2/0194 Registration number: 42/8.2/0195 Registration number: 42/8.2/0196

WALTLOO, PRETORIA WALTLOO, PRETORIA WALTLOO, PRETORIA

Registration number: 42/8.2/0197 Registration 42/8.2/0198 Registration number: 42/20.1.2/0212

Dosage form: INJECTION Dosage form: INJECTION Dosage form: INJECTION

RESEARCH INSTITUTE FOR INDUSTRIAL

MRF 15 MRF15 vIRF 15

Registration number: 42/20.1.2/0213 Registration number: 42/20.1.1/0251 42/20.1.1/0252

Shelf-life: 24 months Shelf-life: 24 months (Provisional) 24 months (Provisional)

Registration number: 42/26/0962 Registration number: 43/5.4.1/0133 Registration number: 43/5.4.1/0134

WEST, JOHANNESBURG, RSA

Registration number: 43/5.4.110135 Registration number: Registration number

SERVICES, SILVERTONDALE, PRETORIA, BUSINESS PARK, PHARMA-Q (PTY) LTD, INDUSTRIA

MRF 15 MRF15 2,F 15

Registration number: 43/20.1.1/0190 Registration number: 43/20.1.1/0191 Registration number: 43/26/0246

Dosage form: TABLET Dosage form: TABLET Dosage form: INJECTION

PRETORIA, RSA RSA

Registration number: 43/7.1.3/0301 Registration number: 43/7.1.3/0302 Registration number: 43/7.1.3/0303

LABORATORIES (PTY) LTD,

Shelf-life: 36 months Shelf-life: 36 months Shelf-life: 36 months

SABS COMMERCIAL (PTY) SABS COMMERCIAL (PTY)

Registration number: 43/5.4.1/0505 Registration number: 43/5.4.1/0506 Registration number: 43/5.4.1/0507

ATLASVILLE, BOKSBURG, CONSULTING CHEMICAL ATLASVILLE, BOKSBURG, RSA

PHARMACY, NORTH-WEST PHARMACEUTICAL CHEMISTRY

Shelf-life: 24 months Shelf-life: 36 months Shelf-life: 24 months (Provisional)

Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional)

Registration number: 43/2.6.5/0853 Registration number: 43/2.6.5/0854 Registration number: 43/21.3/0869

Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Shelf-life: 36 months

Registration number: 43/11.4.3/1089 Registration number: 43/11.4.3/1090 Registration number: 43/7.5/1107

Dosage form: TABLET Dosage form: TABLET Dosage form: TABLET

Date of registration: 26 OCTOBER 2012

& DEVELOPMENT), AEROTON, (RESEARCH & DEVELOPMENT), ADCOCK INGRAM LTD

MRF 15 MRF15 MRF 15

Registration number: 43/7.5/1111 Registration number: 43/7.5/1112 Registration number: 43/7.5/1113

& DEVELOPMENT), AEROTON, (RESEARCH & DEVELOPMENT), ADCOCK INGRAM LTD

Registration number: 43/7.5/1117 Registration number: 43/7.5/1118 Registration number: 43/7.5/1119

AEROTON, JOHANNESBURG, RSA (RESEARCH &

Registration number: 43/7.5/1120 Registration number: 43/7.5/1121 Registration number: 44/13.4.1/0095

MRF 15 MRF15 MRF 15

Registration number: 44/26/0098 Registration number: 44/26/0099 Registration number: 44/26/0100

PARK, SANDTON, RSA BOKSBURG, RSA

Registration number: 44/10.2.2/0829 Registration number: 44/10.2.2/0830 Registration number: 44/10.2.2/0831

Registration number: 44/20.2.3/0863 Registration number: 44/20.2.3/0864 Registration number: 44/10.2.2/0912

Registration number: 44/10.2.2/0913 Registration number: 44/10.2.2/0914 Registration number: 44/10.1/0925

TECHNIKON LABORATORIES (PTY)

Registration number: 44/10.1/0927 Registration number: 46/20.2.8/0760 Registration number: 46/20.2.8/0682

LTD, ROBERTVILLE EXTENSION,

Shelf-life: 60 months (Aluminium tubes) Shelf-life: 36 months Shelf-life: 24 months

Registration number: 44/26/0960 Registration number: 44/26/0961 Registration number: 44/26/0962

LABORATORIES, FERNDALE, PHARMASPEC CONSULTING RSA

Registration number: 44/26/0963 Registration number: 44/26/0964 Registration number: 44/26/0965

RANDBURG, RSA CONSULTING