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  • List of Nationally Authorised Medicinal Products: Active Substance: Nifuroxazide

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    Omar Nassir Moftah
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    This document lists nationally authorized medicinal products containing the active substance nifuroxazide. It provides the product name, MRP/DCP authorization number if applicable, national authorization number, marketing authorization holder, and member state where authorized for each product. A total of 47 products authorized across 15 European countries are included in the list.

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    202108_en

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    This document lists nationally authorized medicinal products containing the active substance nifuroxazide. It provides the product name, MRP/DCP authorization number if applicable, national authorization number, marketing authorization holder, and member state where authorized for each product. A total of 47 products authorized across 15 European countries are included in the list.

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    © All Rights Reserved
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    1 views9 pages

    List of Nationally Authorised Medicinal Products: Active Substance: Nifuroxazide

    Uploaded by

    Omar Nassir Moftah
    This document lists nationally authorized medicinal products containing the active substance nifuroxazide. It provides the product name, MRP/DCP authorization number if applicable, national authorization number, marketing authorization holder, and member state where authorized for each product. A total of 47 products authorized across 15 European countries are included in the list.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 9

    22 April 2022

    EMA/738449/2021
    Human Medicines Evaluation Division

    List of nationally authorised medicinal products

    Active substance: nifuroxazide

    Procedure no.: PSUSA/00002160/202108

    Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands


    Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
    Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union

    © European Medicines Agency, 2022. Reproduction is authorised provided the source is acknowledged.
    Product Name (in authorisation MRP/DCP National Authorisation MAH of product in the Member State where
    country) Authorisation number Number member state product is authorised
    PANFUREX 4%, suspension buvable not available 34009 327 559 4 3 BOUCHARA RECORDATI FR

    PANFUREX 200 mg, gélule not available 34009 267 050 3 9 BOUCHARA RECORDATI FR

    PANFUREX 200 mg, gélule not available 34009 327 558 8 2 BOUCHARA RECORDATI FR

    PANFUREX 200 mg, gélule not available 34009 554 915 6 9 BOUCHARA RECORDATI FR

    PANFURYL 200 mg, gélule not available 34009 347 745 8 4 BOUCHARA RECORDATI FR

    PANFUREX Gé 4 %, suspension not available 0182601 BOUCHARA RECORDATI LU


    buvable

    PANFUREX 200 mg, gélule not available 0182595 BOUCHARA RECORDATI LU

    ERCEFURYL 200 mg, gélule not available 34009 381 125 9 7 OPELLA HEALTHCARE FRANCE FR
    SAS

    NIFUROKSAZYD POLFARMEX, 100 not available 23419 POLFARMEX S.A. PL


    mg, tabletki powlekane

    List of nationally authorised medicinal products


    EMA/738449/2021 Page 2/9
    Product Name (in authorisation MRP/DCP National Authorisation MAH of product in the Member State where
    country) Authorisation number Number member state product is authorised
    NIFUROKSAZYD POLFARMEX, 200 not available 23423 POLFARMEX S.A. PL
    mg, tabletki powlekane

    NIFUROKSAZYD POLFARMEX, 220 not available 23424 POLFARMEX S.A. PL


    mg/5 ml, zawiesina doustna

    DIAFURYL 200 mg, gélule not available 34009 354 889 1 6 COOPERATION FR
    PHARMACEUTIQUE
    FRANCAISE
    DIAFURYL 200 mg, gélule not available 34009 354 889 1 6 COOPERATION FR
    PHARMACEUTIQUE
    FRANCAISE
    DIAFURYL 200 mg, gélule not available 34009 354 889 1 6 COOPERATION FR
    PHARMACEUTIQUE
    FRANCAISE
    ZYFURAX BABY, 220 mg/5 ml, not available 21801 HASCO-LEK PL
    zawiesina doustna

    NIFUROKSAZYD 200 HASCO, 200 not available 14139 HASCO-LEK PL


    mg, tabletki powlekane

    NIFUROKSAZYD HASCO 100 mg not available 10897 HASCO-LEK PL


    tabletki powlekane

    NIFUROKSAZYD HASCO 220 mg/5 not available 8346 HASCO-LEK PL


    ml zawiesina doustna

    List of nationally authorised medicinal products


    EMA/738449/2021 Page 3/9
    Product Name (in authorisation MRP/DCP National Authorisation MAH of product in the Member State where
    country) Authorisation number Number member state product is authorised
    ZYFURAX JUNIOR, 100 mg, tabletki not available 18332 HASCO-LEK PL
    powlekane

    ZYFURAX FORTE, 200 mg, tabletki not available 18545 HASCO-LEK PL


    powlekane

    NIFUROXAZIDE EG LABO CONSEIL not available NL24961 EG LABO LABORATOIRES FR


    200 mg, gélule EUROGENERICS

    ERCEFURYL not available 21203/24-07-1991 SANOFI-AVENTIS AEBE GR

    ERCEFURΥL not available 21204/24-07-1991 SANOFI-AVENTIS AEBE GR

    ERCEFURYL not available 21203/24-07-1991 SANOFI-AVENTIS AEBE GR

    ERCEFURYL not available 21203/24-07-1991 SANOFI-AVENTIS AEBE GR

    ERCEFURYL 200 mg, gélule not available 34009 381 125 9 7 OPELLA HEALTHCARE FRANCE FR
    SAS

    NIFUROKSAZYD GEDEON RICHTER, not available R/1109 GEDEON RICHTER POLSKA PL


    100 mg, tabletki powlekane SP. Z. O.O.

    List of nationally authorised medicinal products


    EMA/738449/2021 Page 4/9
    Product Name (in authorisation MRP/DCP National Authorisation MAH of product in the Member State where
    country) Authorisation number Number member state product is authorised
    ERCEFURYL 200 mg, gélule not available 34009 381 125 9 7 OPELLA HEALTHCARE FRANCE FR
    SAS

    BACTÉRIX 200 mg, gélule not available 34009 359 587 3 0 GIFRER BARBEZAT FR

    NIFUROXAZIDE ARROW 200 mg, not available NL 27010 ARROW GENERIQUES FR


    gélule

    DIAFURYL 200 mg, gélule not available 34009 354 889 1 6 COOPERATION FR
    PHARMACEUTIQUE
    FRANCAISE
    PANFUREX 4%, suspension buvable not available 34009 327 559 4 3 BOUCHARA RECORDATI FR

    PANFUREX 200 mg, gélule not available 34009 267 050 3 9 BOUCHARA RECORDATI FR

    PANFUREX 200 mg, gélule not available 34009 327 558 8 2 BOUCHARA RECORDATI FR

    PANFUREX 200 mg, gélule not available 34009 554 915 6 9 BOUCHARA RECORDATI FR

    PANFURYL 200 mg, gélule not available 34009 347 745 8 4 BOUCHARA RECORDATI FR

    List of nationally authorised medicinal products


    EMA/738449/2021 Page 5/9
    Product Name (in authorisation MRP/DCP National Authorisation MAH of product in the Member State where
    country) Authorisation number Number member state product is authorised
    PANFUREX Gé 4 %, suspension not available 0182601 BOUCHARA RECORDATI LU
    buvable

    PANFUREX 200 mg, gélule not available 0182595 BOUCHARA RECORDATI LU

    Ercefuryl 200 mg tvrdé tobolky not available 42/622/97-C TAKEDA GMBH CZ

    NIFUROXAZIDE ARROW 200 mg, not available NL 27010 ARROW GENERIQUES FR


    gélule

    NIFUROXAZIDE ZENTIVA 200 mg, not available 34009 324 163 2 5 ZENTIVA FRANCE FR
    gélule

    NIFUROXAZIDE ZENTIVA 200 mg, not available 34009 367 469 6 1 ZENTIVA FRANCE FR
    gélule

    NIFUROXAZIDE ZENTIVA 200 mg, not available 34009 324 164 9 3 ZENTIVA FRANCE FR
    gélule

    Nifuroxazide Teva 200 mg, gelule not available NL23914 TEVA SANTÉ FR

    NIFUROXAZIDE ARROW 200 mg, not available NL 27010 ARROW GENERIQUES FR


    gélule

    List of nationally authorised medicinal products


    EMA/738449/2021 Page 6/9
    Product Name (in authorisation MRP/DCP National Authorisation MAH of product in the Member State where
    country) Authorisation number Number member state product is authorised
    ERCEFURYL 200 mg, gélule not available 34009 381 125 9 7 OPELLA HEALTHCARE FRANCE FR
    SAS

    DIARINE Πόσιμο Εναιώρημα 220 not available 39989/08/15-12-2017 LAVIPHARM S.A GR


    mg/5 ml

    NIFUROKSAZYD POLFARMEX, 100 not available 23419 POLFARMEX S.A. PL


    mg, tabletki powlekane

    NIFUROKSAZYD POLFARMEX, 200 not available 23423 POLFARMEX S.A. PL


    mg, tabletki powlekane

    NIFUROKSAZYD POLFARMEX, 220 not available 23424 POLFARMEX S.A. PL


    mg/5 ml, zawiesina doustna

    NIFUROKSAZYD GEDEON RICHTER, not available R/1108 GEDEON RICHTER POLSKA PL


    220 mg/5 ml, zawiesina doustna SP. Z. O.O.

    ERCEFURYL not available 21203/24-07-1991 SANOFI-AVENTIS AEBE GR

    ERCEFURΥL not available 21204/24-07-1991 SANOFI-AVENTIS AEBE GR

    ERCEFURYL not available 21203/24-07-1991 SANOFI-AVENTIS AEBE GR

    List of nationally authorised medicinal products


    EMA/738449/2021 Page 7/9
    Product Name (in authorisation MRP/DCP National Authorisation MAH of product in the Member State where
    country) Authorisation number Number member state product is authorised
    ERCEFURYL not available 21203/24-07-1991 SANOFI-AVENTIS AEBE GR

    PANFUREX 4%, suspension buvable not available 34009 327 559 4 3 BOUCHARA RECORDATI FR

    PANFUREX 200 mg, gélule not available 34009 267 050 3 9 BOUCHARA RECORDATI FR

    PANFUREX 200 mg, gélule not available 34009 327 558 8 2 BOUCHARA RECORDATI FR

    PANFUREX 200 mg, gélule not available 34009 554 915 6 9 BOUCHARA RECORDATI FR

    PANFURYL 200 mg, gélule not available 34009 347 745 8 4 BOUCHARA RECORDATI FR

    PANFUREX Gé 4 %, suspension not available 0182601 BOUCHARA RECORDATI LU


    buvable

    PANFUREX 200 mg, gélule not available 0182595 BOUCHARA RECORDATI LU

    ERCEFURYL 200 mg, gélule not available 34009 381 125 9 7 OPELLA HEALTHCARE FRANCE FR
    SAS

    List of nationally authorised medicinal products


    EMA/738449/2021 Page 8/9
    Product Name (in authorisation MRP/DCP National Authorisation MAH of product in the Member State where
    country) Authorisation number Number member state product is authorised
    NIFUROKSAZYD GEDEON RICHTER, not available 17650 GEDEON RICHTER POLSKA PL
    200 mg, kapsułki twarde SP. Z. O.O.

    NIFUROXAZIDE MYLAN 200 mg, not available NL 23062 MYLAN S.A.S FR


    gélule

    Ercefuryl 200 mg tvrdé tobolky not available 42/622/97-C TAKEDA GMBH CZ

    ERCEFURYL 200 mg, gélule not available 34009 381 125 9 7 OPELLA HEALTHCARE FRANCE FR
    SAS

    DIAFURYL 200 mg, gélule not available 34009 354 889 1 6 COOPERATION FR
    PHARMACEUTIQUE
    FRANCAISE
    NIFUROKSAZYD POLFARMEX, 100 not available 23419 POLFARMEX S.A. PL
    mg, tabletki powlekane

    NIFUROKSAZYD POLFARMEX, 200 not available 23423 POLFARMEX S.A. PL


    mg, tabletki powlekane

    NIFUROKSAZYD POLFARMEX, 220 not available 23424 POLFARMEX S.A. PL


    mg/5 ml, zawiesina doustna

    NIFUROXAZIDE TEVA CONSEIL 200 not available NL28935 TEVA SANTÉ FR


    mg, gélule

    List of nationally authorised medicinal products


    EMA/738449/2021 Page 9/9

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