Cytarabine Accord Reg Eng

Signatory: Dr. Annamária Gara (2018.04.09.
11:35:38)
(logo)
OGYÉI
National Institute of Pharmacy and Nutrition
1051 Budapest, Zrínyi Street 3.

Mailing address: PO Box 1372, Box 450.
Tel: (1) 8869-300, Fax: (1) 8869-460
Email: ogyei@ogyei.gov.hu , Web: www.ogyei.gov.hu
Renewal date: 2018.04.09

Registration number: OGYU5837-3/2014
Official: Hollós A. Zsófia
Subject: renewal of Marketing Authorization
Accord Healthcare Limited

Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
Represented by:
ONCO-EUROPE KFT
2360 Gyál, Gyál 7000/9.hrsz.
Tax ID:
13957476-2-13
DECISION
Acting pursuant to the authorization provided in Section 5 (1) of Act XCV of 2005 amending laws
regulating the pharmaceutical market and medicines for human use (hereinafter referred to as:
Pharmaceutical Act), Accord Healthcare Limited (hereinafter referred to as: Applicant) submitted a
request to the National Institute of Pharmacy and Nutrition (hereinafter referred to as: OGYÉI) on
February 10, 2014, under case number OGYU5837/2014, for the renewal of marketing authorization for
the medicinal product named Cytarabine Accord 100 mg/ml solution for injection or infusion, in an
international procedure.
I hereby issue the following
decision.
The Applicant, holding a valid marketing authorization until March 20, 2018, for the product named
Cytarabine Accord 100 mg/ml solution for injection or infusion, issued following a careful re-evaluation
of the latest data concerning the quality, efficacy, relative safety, and reported adverse reactions of the
medicinal product, pursuant to Section 5 (7) of the Pharmaceutical Act and Sections 31 (1)-(2) of the
Regulation on the Marketing Authorization of Medicinal Products for Human Use (hereinafter referred to
as: Regulation), hereby renews the marketing authorization indefinitely, as detailed below.
1.) The name of the medicinal product (trademarked name, strength, pharmaceutical form):
Cytarabine Accord 100 mg/ml solution for injection or infusion
2.) The packaging of the medicinal product (packaging unit, packaging method) and the
registration number(s) of the medicinal product:
1X1 ml - Type I 2 ml glass vial - OGYI-T-22451/01

2.a) International reference number:

UK/11/1641/001/E001
3.) The name and registered office of the marketing authorization holder:
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom
4.) The name and registered office/site of the manufacturer responsible for batch release of
the medicinal product:
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow,
5.) The active substance(s) of the medicinal product:

Cytarabine
With the legal force of this decision, in accordance with Section 5 (10) and Section 10 (2) of
the Pharmaceutical Act - the marketing authorization of the medicinal product, in addition
to what is contained in the original documentation, shall include the following
modifications:
a) OGYÉY/45860/2016 UK/H/1641/001/IB/021
Type IB.B.11.b.4.z - Increase in batch size of the product.
b) OGYÉY/55071/2016 UK/11/1641/IA/022/G
Type 1A B.II.e.3.b - Compliance of glass specifications with the European Pharmacopoeia.
1A B.III.2.b - Addition of IPC testing procedure for rubber stopper.
c) OGYÉY/62156/2017 UK/H/1641/001/IB/023
Type IB.B.II.b.4.z - Increase in batch size of the product.
d) OGYÉV823/2018 UK/H/1641/001/IB/024
Type IB B.III.1.a.3 - Introduction of a new active substance manufacturing site with CEP.
Accord Health Polska Sp. z o.o.

02-677 Warsaw, ul. Taśmowa 7
Tax Identification Number (NIP): 1070015415,
National Official Business Register Number (REGON): 142248997
KRS (National Court Register) Number: 0000347170
With the legal force of this decision, pursuant to Section 26 (6) of the Pharmaceutical Act, there is no
possibility of appeal within the framework of administrative proceedings. However, within 30 days of
receipt of the decision, pursuant to Section 109 (1) of Act CXL of 2004 on the General Rules of
Administrative Proceedings and Services (hereinafter: Ket.), a request for judicial review may be
submitted to the Budapest Administrative and Labor Court, citing a violation of the law. The request for
judicial review shall be submitted to the National Institute of Pharmacy and Nutrition.
Justification
The Applicant, in their letter dated February 04, 2014, regarding the product Cytarabine Accord 100
mg/ml solution for injection or infusion, which holds a valid marketing authorization until March 20,
2018, and fully complies with the conditions set forth in Section 31 (2) of the Regulation, has submitted a
request for renewal of marketing authorization pursuant to Section 5 (7) of the Pharmaceutical Act to
the National Institute of Pharmacy and Nutrition.
The National Institute of Pharmacy and Nutrition examined the received request and the accompanying
documentation. During the examination, the latest data on the quality, relative safety, efficacy,
risk/benefit ratio, and reported adverse reactions of the medicinal product were re-evaluated.
As a result of the examination, it was determined that the product fully complies with the statutory
requirements set forth in Section 5 (7) of the Pharmaceutical Act and in Section 31 (1)-(4) of the
Regulation. The Applicant has timely fulfilled the obligation to pay the fee pursuant to Section 25/B of
the Pharmaceutical Act and its Annex No. 1.
Based on the above, the renewal of the product is permissible, therefore I have made the decision as set
forth in the dispositive part.
A copy of this decision and its attachments (except Annexes No. 3 and No. 4) will be sent by the National
Institute of Pharmacy and Nutrition to the National Health Insurance Fund Administration pursuant to
Section 15 (6) of the Regulation.
The possibility of appeal is precluded by Section 26 (6) of the Pharmaceutical Act, while the possibility
of judicial review is provided for by Section 109 of Act CXL of 2004.
The National Institute of Pharmacy and Nutrition made this decision within its statutory powers, acting
pursuant to the designation set forth in Section 4 (1) of Government Decree No. 28/2015 (II.25.) on the
National Institute of Pharmacy and Nutrition.
Budapest,
Attachments:
1.) Attachment No. 1: Composition, description, packaging
2.) Attachment No. 2: Annexes (Instructions for use, patient information leaflet, label)
3.) Attachment No. 3: Full composition, description, packaging (confidential attachment containing
sensitive data - only accessible to the applicant)
4.) Attachment No. 4: Manufacturing sites (confidential attachment containing sensitive data - only
accessible to the applicant)

Attachment No. 1: COMPOSITION, DESCRIPTION, PACKAGING
1) Composition
1.1 Official name(s) and quantity of the active ingredient(s) in Hungary
Composition per unit:
One vial for 1 ml 5 ml 10 ml 20 ml

injection
Citarabin 100 mg 500 mg 1000 mg 2000 mg
One vial for 40 ml 50 ml

injection
Citarabin 4000 mg 5000 mg
1.2 Listing of excipients in Hungary only, without indicating their quality and quantity:
Macrogol 400, trometamol (pH adjustment), water for injection, nitrogen (inert gas)
2. Description
2.1. Description of the product
Clear, colorless solution, practically free from particles.
2.2. Product packaging:
1 ml injection solution:
In Type I 2 ml glass vial, sealed with a 13 mm gray rubber stopper and a 13 mm aluminum cap, and
covered with a transparent, blue or royal blue flip-off plastic cap.
In Type I 5 ml tubular glass vial, sealed with a 20 mm gray rubber stopper and a 20 mm aluminum cap,
and covered with a transparent, blue or royal blue flip-off plastic cap.
covered with a royal blue flip-off plastic cap.
covered with a violet flip-off plastic cap.

Attachment No. 2: PACKAGE INSERT:
INSTRUCTIONS FOR USE
The Instructions for Use under OGYI/33538/2014 remain valid.
PATIENT INFORMATION LEAFLET
The Patient Information Leaflet under OGYI/33538/2014 remains valid.
LABEL TEXT
The Label Text under OGYI/16334/2013, OGYI/20185/2013, OGYI/4180/2014 remains valid.

(logo)
OGYÉI

Tel: (1) 8869-300, Fax: (1) 8869-460
Renewal date: 2018.04.09

Registration number: OGYU5837-3/2014
Official: Hollós A. Zsófia
Subject: renewal of Marketing Authorization
ATTACHMENTS CONTAINING CONFIDENTIAL INFORMATION

2.) Packaging of the medicinal product (packaging unit, packaging method) and the registration
number(s) of the medicinal product:

UK/11/1641/001/E001
a) name: Accord Healthcare Limited
b) address: Sage House, 319 Pinner Road, North Harrow,
Attachment No. 3: TOTAL QUANTITATIVE COMPOSITION, PHARMACEUTICAL FORM

PER UNIT, DESCRIPTION, PACKAGING (in English)
Total quantitative composition:

Composition:
One vial contains: 1 ml 5ml 10ml 20ml
Cytarabine 100mg 500mg 1000mg 2000mg
Macrogol 400 150.0 750 1500 3000

Trometamol q.s. q.s. mg mg q.s. mg q.s.
(used as 10 % w/v ution in water for injection for pH
sol Water for q.s. to 1 ml adjustment) q.s. to 20 ml
injections q.s. to 5 ml q.s. to 10 ml
Nitrogen (inert gas) q.s. q.s. q.s. q.s.
One vial contains: 40 ml 50 ml

Cytarabine 4000mg 5000 mg
Macrogol 400 6000 mg 7500 mg

Trometamol q.s. q.s.
(used as 10 % w/v solution in waterfor injection for pH adjustment)
Water for injections q.s. to 40 ml q.s. to 50 ml
Nitrogen (inert gas) q.s. q.s.
2. Description
Appearance:
2.2. Packaging of the product:
Packaging:
For 1 ml,
Solution for injection is filled in 2 ml Type - I clear glass vial closed with 13 mm grey rubber
stopper and 13 mm aluminum flip-off transparent blue seal/13 mm aluminum flip off royal blue
seal.
For 5 ml,
Solution for injection is filled in 5 ml Type - I clear tubular glass vial closed with 20 mm grey
rubber stopper and 20 mm aluminum flip-off transparent blue seal/20 mm aluminum flip off
royal blue seal.
For 10 ml vials:
royal blue seal.
For 20 ml vials:
stopper and 20 mm aluminum flip-off royal blue seal.
For 40 ml vials:
For 50 ml vials:
stopper and 20 mm aluminum flip-off royal violet seal.

Attachment No. 4: MANUFACTURING SITES
1.) Manufacturer(s) of the finished product and the place(s) of manufacture, with a description of
the operations carried out
Manufacturing and packaging:
a) Name: Intas Pharmaceuticals Limited
b) Address: Plot No. 457-458, Sarkhej-Bavla Highway, Matoda, Tat. Sanand, Ahmedabad - 382210,
India
Secondary packaging:
a) Name: Accord Healthcare Limited
b) Address: Unit C&D, Homefield Business park, Homefield Road, Haverhill, CB9 8QP, United
Kingdom
2.) Location responsible for the release of manufacturing batches distributed in Hungary
b) Address: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
3.) Manufacturer(s) of the active ingredient(s)
Holder:
a) Name: EUTICALS SPA
b) Address: Viala Bianca Maria, 25, 20122 Milano, Italy
Site:
b) Address: Via Valverde 20/22, 21100 Varese, Italy
Holder:
a) Name: Zhejiang Hisun Pharmaceutical Co., Ltd.
b) Address: 46 Waisha Road, Jiaojiang District, Tiazhin City, Zhejiang Province 318000, China
Site:
b) Address: 56 Binhai Road, Jiaojiang District, Tiazhin City, Zhejiang Province 318000, China
Holder:
a) Name: Mac Chem Products (India) Pvt. Ltd.
b) Address: 304, Town Centre, Andheri Kurta Road, Andheri (East), Mumbai, Maharashtra, 400
059 India
4.) Contracted companies entrusted with the bioavailability/equivalence study or, in the case of
blood products, their verification (per product)
Note: Attachments 3 and 4 are accessible exclusively to the marketing authorization holder as they
contain confidential information.

Signatory: Dr. Gara Annamária (2020.04.20. 10:00:15)

(logo)
OGYÉI

Tel: (1) 8869-300, Fax: (1) 8869-460
Date of modification: 2020-04-20.

Reference number: OGYÉI/59908-4/2019
Administrator: Krisztina Mucsányiné Juhász
Subject: Modification of marketing authorization
Accord Healthcare Polska Sp. z o.o.,

Tasmowa 7 str.,
02-677 Warsaw,
Poland
Represented by:
Onco-Europe Ltd.
Tax number: 13957476
Acting pursuant to the authorization provided in Section 5 (1) of Act XCV of 2005 amending laws
regulating medicines for human use and other pharmaceutical market regulations (hereinafter referred to
as: Pharmaceutical Act), on October 3, 2019, upon the request of Accord Healthcare Polska Sp. z o.o.,
(hereinafter referred to as: Applicant), the National Institute of Pharmacy and Nutrition (hereinafter
referred to as: OGYÉI) initiated a procedure for the modification of the marketing authorization of the
medicinal product named Cytarabine Accord 100 mg/ml solution for injection or infusion (hereinafter
referred to as: Product). I hereby issue the following
decision
Regarding the Product Cytarabine Accord 100 mg/ml solution for injection or infusion, the marketing
authorization granted on March 20, 2013, under reference number OGYI/36720-12/2012, in my decision,
with the previous modifications integrated into a cohesive structure (hereinafter referred to as: original
decision), is now modified in the subsequent manner:
Upon the finalization of this decision, the operative part of the original decision shall be replaced by the
amended operative part as supplemented with the following modifications:
1.) The name of the medicinal product (trademarked name, strength, pharmaceutical form):
2.) The packaging of the medicinal product (packaging unit, packaging method) and the
registration number(s) of the medicinal product:


NL/H/4561/001/DC (régebbi:UK/H/1641/001/DC)
Accord Healthcare Polska Sp. z o.o., ul. Tasmowa 7, 02-677 Warsaw, Poland
4.) The name, registered office, and site responsible for the release of the medicinal product:
Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
5.) The active ingredient(s) of the medicinal product:

Cytarabine
6.) Appendix 1 shall be amended as follows:

The Appendix 1 of this decision shall replace the Appendix 1 of the current decision.



10.) In accordance with Section 5 (10) of the Pharmaceutical Act, the marketing authorization of
the medicinal product shall be supplemented with the following:
a) OGYÉI/47011/2018 NL/H/4561/001/P/001 (UK/11/1641/001/P/001) N61(3) notification

(serialization) (labeling text modification)
b) OGYÉI/12410/2019 MAH transfer (old MAH: Accord Healthcare Limited Sage House, 319
Pinner Road North Harrow, Middlesex, HA 1 4HF United Kingdom. New MAH: Accord Healthcare
Polska Sp. z o.o., ul. Tasmowa 7, 02-677 Warsaw, Poland
c) OGYÉI/59908/2019 NL/H/4561/001/IA/026 (UK/11/1641/001/DC) Type 1A B.11.b.l.a.
Replacement of secondary packaging site
These modifications constitute an integral and inseparable part of the original decision and do not
affect its rationale.
Regarding this decision, there is no possibility of appeal within the framework of administrative
proceedings pursuant to Section 26 (6) of the Pharmaceutical Act. However, within 30 days of receiving
notification of the contested administrative action, citing a violation of rights, an administrative lawsuit
may be initiated against the final decision in accordance with Section 114 (1) of Act CL of 2016 on the
General Rules of Administrative Procedure (hereinafter referred to as: Ákr.) before the court specified in
Section 13 (3) of Act I of 2017 on Administrative Litigation Procedure. The statement of claim must be
addressed to the competent court and submitted to the National Institute of Pharmacy and Nutrition.
It is noted that the administrative service fee has been reimbursed. The administrative service fee is borne
by the Client. No other procedural costs arose during this procedure.
Justification
On October 3, 2019, the Applicant submitted a request to the National Institute of Pharmacy and
Nutrition regarding the modification of the marketing authorization for Cytarabine Accord 100 mg/ml
solution for injection or infusion, pursuant to Section 5 (10) of the Pharmaceutical Act.
The National Institute of Pharmacy and Nutrition examined the received request and the accompanying
documentation. During the formal examination, it was determined that the product fully complies with the
conditions set forth in paragraphs (2)-(8) of Section 13 of Government Decree No. 450/2017 (XII. 27.)
on the Authorization and Manufacture of Medicinal Products for Human Use.
Subsequent to this, a substantive assessment of the application and its accompanying documentation was
conducted, with special attention given to the contents of the assessment report submitted by the reference
member state. Upon evaluation, the National Institute of Pharmacy and Nutrition (OGYÉI), in alignment
with the regulatory authorities of the reference member state and other participating member states,
concluded that the quality and quantitative composition of the medicinal product - encompassing
manufacturing conditions - remain well-established and defined. Furthermore, the therapeutic efficacy of
the medicinal product is clinically confirmed, and the benefit-to-risk ratio remains favorable.
The information provided on the immediate or outer packaging, as defined by the Pharmaceutical Act
(hereinafter referred to as the "label"), and the patient information leaflet remain compliant with the
provisions outlined in Sections 8-10 of the Pharmaceutical Act.
Based on the foregoing, the medication fully adheres to the requirements specified in Section 5 (10) of
the Pharmaceutical Act, as well as the legal regulations outlined in the Government Decree.
The Applicant has fulfilled the obligation to pay the fee as mandated by Section 25/B of the
Pharmaceutical Act and its Appendix 1 within the prescribed deadline. The administrative service fee
is the responsibility of the Client. No additional procedural costs have arisen in the course of this
procedure.
In accordance with the consensus reached by the regulatory authorities of the participating member states,
the modification of the marketing authorization for the product is deemed permissible. Therefore, the
decision articulated in the operative section has been rendered.
A copy of this decision and its appendices (excluding Appendices 3 and 4) will be electronically
transmitted to the National Health Insurance Fund Management, as stipulated in Section 11 (5) of the
Government Decree, by the National Institute of Pharmacy and Nutrition.
The possibility of appeal is precluded by Section 26 (6) of the Pharmaceutical Act, while the
opportunity to initiate administrative litigation is governed by Section 114 (1) of the General Rules of
Administrative Procedure (Ákr.).
The decision of the National Institute of Pharmacy and Nutrition embodied in this resolution was
rendered within its jurisdiction as delineated in Section 5 of the Pharmaceutical Act, in accordance with
the designation outlined in Section 4 (1) of Government Decree 28/2015 (II. 25.) concerning the National
Institute of Pharmacy and Nutrition.
Executed in Budapest.
Attachments:
1.) Annex 1: Composition, description, packaging
2.) Annex 2: Supporting documents
3.) Annex 3: Full composition, description, packaging (Confidential information - available only to the
applicant)
4.) Annex 4: Manufacturing sites (Confidential information - available only to the applicant)
Attachment No. 1: COMPOSITION, DESCRIPTION, PACKAGING
1) Composition
1.1 Official name(s) and quantity of the active ingredient(s) in Hungary
Composition per unit:
One vial for 1 ml 5 ml 10 ml 20 ml

injection
Citarabin 100 mg 500 mg 1000 mg 2000 mg
One vial for 40 ml 50 ml

injection
Citarabin 4000 mg 5000 mg
1.2 Listing of excipients in Hungary only, without indicating their quality and quantity:
Macrogol 400, trometamol (pH adjustment), water for injection, nitrogen (inert gas)
2. Description
2.2. Product packaging:
covered with a transparent, blue or royal blue flip-off plastic cap.
covered with a violet flip-off plastic cap.

Attachment 2: PACKAGE INSERT:

ADMINISTRATION INSTRUCTIONS
Attached: Administration Instructions numbered OGYÉl/12410/2019.
PATIENT INFORMATION LEAFLET

Attached: Patient Information Leaflet numbered OGYÉl/12410/2019.
LABEL TEXT
Attached: Label Text numbered OGYÉl/47011/2018.

Attachment No. 3: TOTAL QUANTITATIVE COMPOSITION, PHARMACEUTICAL FORM

PER UNIT, DESCRIPTION, PACKAGING (in English)
1). Total quantitative composition:

Composition:
One vial contains: 1 ml 5ml 10ml 20ml

Cytarabine 100mg 500mg 1000mg 2000mg
Macrogol 400 150.0 750 1500 3000

Trometamol q.s. q.s. mg mg q.s. mg q.s.
(used as 10 % w/v ution in water for injection for pH
sol Water for q.s. to 1 ml adjustment) q.s. to 20 ml
injections q.s. to 5 ml q.s. to 10 ml
Nitrogen (inert gas) q.s. q.s. q.s. q.s.
One vial contains: 40 ml 50 ml

Cytarabine 4000mg 5000 mg
Macrogol 400 6000 mg 7500 mg

Trometamol q.s. q.s.
(used as 10 % w/v solution in waterfor injection for pH adjustment)
Water for injections q.s. to 40 ml q.s. to 50 ml
Nitrogen (inert gas) q.s. q.s.
2. Description
Appearance: Clear, colorless solution, practically free from particles.
2.2. Packaging of the product:

Packaging:
For 1 ml,
stopper and 13 mm aluminum flip-off transparent blue seal/13 mm aluminum flip off royal blue
seal.
For 5 ml,
royal blue seal.
For 10 ml vials:
royal blue seal.
For 20 ml vials:
For 40 ml vials:
For 50 ml vials:
stopper and 20 mm aluminum flip-off royal violet seal.

Attachment No. 4: MANUFACTURING SITES
1.) Manufacturer(s) of the finished product and location(s) of manufacturing, with a description of
the operations performed:
Manufacturing and Packaging:

a) Name: Intas Pharmaceuticals Limited
b) Address: Plot No. 457, 458, Sarkhej-Bavla Highway, Matoda, Tal. Sanand, Ahmedabad - 382210,
India
Secondary Packaging:
b) Address: Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom
2.) Responsible location for the release of batches placed on the Hungarian market:
a) Name: Accord Healthcare Polska Sp. z o.o.,

b) Address: ul. Tasmowa 7, 02-677 Warsaw, Poland
3.) Manufacturer(s) of the active substance(s):
Holder:
b) Address: Viala Bianca Maria, 25, 20122 Milan, Italy
Site:
b) Address: Via Valverde 20/22, 21100 Varese, Italy
Holder:
b) Address: 46 Waisha Road, Jiaojiang District, Taizhou City, Zhejiang Province, 318000, China
Site:
b) Address: 56 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, 318000, China
Holder:
b) Address: 304, Town Centre, Andheri Kurla Road, Andheri (East), Mumbai, Maharashtra 400
059, India
Site:
b) Address: N-211/2/10, M.I.D.C. Boisar, District Thane, Tarapur, Maharashtra 401 506, India
Production of intermediate:
a) Name: Xinxiang Tuoxin Biochemical Co. Ltd.
b) Address: Xinxiang Advanced Technology, Xinxiang, Henan Province, 453 000, China
4.) Companies contracted for conducting bioavailability/bioequivalence studies, or for the

inspection of blood products:
a) Name: ---
b) Address: ---
Note: Appendices 3 and 4 are only provided to the holder of the marketing authorization as they contain
confidential information.

LABELLING
INFORMATION ON THE OUTER PACKAGING
CARTON BOX
1. NAME OF THE MEDICAL PRODUCT

cytarabine
2. ACTIVE SUBSTANCE
Contains 100 mg of cytarabine per milliliter.

Contains 100 mg of cytarabine per 1 ml injection vial.
3. BACKGROUND MATERIAL LIST
macrogol 400, trometamol, water for injections.

For more information see the package leaflet.
4. PHARMACEUTICAL FORMS AND CONTENTS
Solution for injection or infusion.
1X1 ml injection vial.
5. METHODS AND ROUTE (S)
For intravenous or subcutaneous use only.

Before use read the package leaflet.
6. SPECIAL WARNING THAT THE MEDICAL PRODUCT MUST BE STORED OUT OF

THE RICH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7. OTHER SPECIAL WARNING (S), IF NECESSARY
The product must be used immediately after first opening.

For shelf life after reconstitution, refer to the patient information leaflet.
For single use only.
CYTOSTATIC AGENT.
8. EXPIRY DATE
EXP: {MM / YYYY}
9. SPECIAL STORAGE CONDITIONS

Store at a maximum of 25°C.
Do not store in a refrigerator!
Do not freeze!
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. MARKETING AUTHOSIZATION HOLDER NAME AND ADDRESS
Accord Healthcare Polska Sp. z o.o.

ul. Tasmowa 7,
02-677 Warsaw
Poland
12. REGISTRATION NUMBER
13. BATCH NUMBER
Series:
14. SALES (LICENSING) ORDER
Obtained with medical prescription.
15. INSTRUCTIONS FOR USE
16. INFORMATION IN BRAILLE

Cytarabine Accord Reg Eng

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Signatory: Dr. Annamária Gara (2018.04.09.

1051 Budapest, Zrínyi Street 3.

Renewal date: 2018.04.09

Accord Healthcare Limited

1X1 ml - Type I 2 ml glass vial - OGYI-T-22451/01

2.a) International reference number:

5.) The active substance(s) of the medicinal product:

Accord Health Polska Sp. z o.o.

Accord Health Polska Sp. z o.o.

Attachment No. 1: COMPOSITION, DESCRIPTION, PACKAGING

Composition per unit:

One vial for 1 ml 5 ml 10 ml 20 ml

One vial for 40 ml 50 ml

Accord Health Polska Sp. z o.o.

Attachment No. 2: PACKAGE INSERT:

INSTRUCTIONS FOR USE

The Instructions for Use under OGYI/33538/2014 remain valid.

PATIENT INFORMATION LEAFLET

The Patient Information Leaflet under OGYI/33538/2014 remains valid.

The Label Text under OGYI/16334/2013, OGYI/20185/2013, OGYI/4180/2014 remains valid.

Accord Health Polska Sp. z o.o.

1051 Budapest, Zrínyi Street 3.

Renewal date: 2018.04.09

ATTACHMENTS CONTAINING CONFIDENTIAL INFORMATION

Cytarabine Accord 100 mg/ml solution for injection or infusion

2.a) International reference number:

Attachment No. 3: TOTAL QUANTITATIVE COMPOSITION, PHARMACEUTICAL FORM

Total quantitative composition:

Macrogol 400 150.0 750 1500 3000

One vial contains: 40 ml 50 ml

Macrogol 400 6000 mg 7500 mg

Accord Health Polska Sp. z o.o.

Attachment No. 4: MANUFACTURING SITES

3.) Manufacturer(s) of the active ingredient(s)

Accord Health Polska Sp. z o.o.

Signatory: Dr. Gara Annamária (2020.04.20. 10:00:15)

1051 Budapest, Zrínyi Street 3.

Date of modification: 2020-04-20.

Accord Healthcare Polska Sp. z o.o.,

1X1 ml - Type I 2 ml glass vial - OGYI-T-22451/01

2.a) International reference number:

5.) The active ingredient(s) of the medicinal product:

6.) Appendix 1 shall be amended as follows:

7.) Appendix 2 shall be amended as follows:

8.) Appendix 3 shall be amended as follows:

9.) Appendix 4 shall be amended as follows:

a) OGYÉI/47011/2018 NL/H/4561/001/P/001 (UK/11/1641/001/P/001) N61(3) notification

Composition per unit:

One vial for 1 ml 5 ml 10 ml 20 ml

One vial for 40 ml 50 ml

Accord Health Polska Sp. z o.o.

Attachment 2: PACKAGE INSERT:

PATIENT INFORMATION LEAFLET

Accord Health Polska Sp. z o.o.

Attachment No. 3: TOTAL QUANTITATIVE COMPOSITION, PHARMACEUTICAL FORM

1). Total quantitative composition:

One vial contains: 1 ml 5ml 10ml 20ml

Macrogol 400 150.0 750 1500 3000

One vial contains: 40 ml 50 ml

Macrogol 400 6000 mg 7500 mg

2.2. Packaging of the product:

Accord Health Polska Sp. z o.o.

Attachment No. 4: MANUFACTURING SITES

Manufacturing and Packaging: