List of nationally authorised medicinal products
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1 3 December 2015 EMA/98477/2016 Procedure Management and Committees Support Active substance: acarbose Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 National Number Acarbosa Apotex Apotex Europe B.V. Spain Acarbosa Apotex Apotex Europe B.V. Spain Acarbosa Mylan DE/H/0869/001 $ DE/H/0869/002/DC $ Mylan Pharmaceuticals S.L. Spain Acarbosa Qualigen $ Qualigen, S.L. Spain Acarbosa Tarbis $ Tarbis Farma, S.L. Spain Acarbosa Tecnigen $ Tecnimede España Ind. Fca., S.A. Spain Acarbose PT/H/0662/02/DC PL 25258/0092 Glenmark Pharmaceuticals Europe Limited United Kingdom Acarbose 30306/0567 $ 30306/ /0567 $ 30306/0568 Actavis Group Ptc Ehf. United Kingdom Acarbose UK/H/5049/001 $ UK/H/5049/002/DC PL 04569/1619 $ PL 04569/1620 Generics [uk] Limited United Kingdom EMA/98477/2016 Page 2/10
3 National Number Acarbose PT/H/0662/01/DC PL 25258/0091 Glenmark Pharmaceuticals Europe Limited United Kingdom Acarbose UK/H/5049/001 $ UK/H/5049/002/DC PA 0577/171/001 $ PA 0577/171/002 Mcdermott Laboratories Ltd Ireland Acarbose $ $ $ $ $ $ $ Pentafarma - Sociedade Tecnico-Medicinal S.A. Acarbose NL 19888, NL Bayer HealthCare France Acarbose 1 A Pharma $ A Pharma Gmbh Germany Acarbose Abz $ Abz-Pharma Gmbh, Graf- Arco-Str. 3 Germany Acarbose Al $ Aliud Pharma Gmbh Germany Acarbose Arrow $ Laboratoires Gerda France Acarbose Biogaran 36088, Biogaran France EMA/98477/2016 Page 3/10
4 National Number Acarbose Bluepharma 07/H/0199/ Bluepharma Genéricos - Comércio De Medicamentos, S.A. Acarbose Bluepharma 07/H/0199/ Bluepharma Genéricos - Comércio De Medicamentos, S.A. Acarbose Bluepharma 07/H/0199/ Bluepharma Genéricos - Comércio De Medicamentos, S.A. Acarbose Bluesar PT/H/0662/01/DC $ PT/H/0662/02/DC $ $ Bluepharma Indústria Farmacêutica S.A. Acarbose Dna Pharma 07/H/0198/001 $ 07/H/0198/002 Dna Pharma, Lda Acarbose Dura DE/H/0869/002/DC Mylan Dura Gmbh Germany Acarbose Dura DE/H/0869/001/DC Mylan Dura Gmbh Germany Acarbose Farmoz $ $ $ $ $ $ $ Acarbose Friulchem $ $ $ $ $ Farmoz - Sociedade Técnico Medicinal, S.A. Friulchem Spa EMA/98477/2016 Page 4/10
5 National Number Acarbose Generis $ $ Generis Farmacêutica, S.A. Acarbose Hexal $ Hexal Ag Germany Acarbose Labesfal $ $ Labesfal Genéricos, S.A. Acarbose Mylan NL $ NL Mylan S.A.S France Acarbose Mylan DE/H/0869/001 $ DE/H/0869/002/DC $ $ $ Mylan, Lda Acarbose Mylan DE/H/0869/001 $ DE/H/0869/002/DC OGYI-T-20981/01 $ OGYI-T /02 $ OGYI-T-20981/03 $ OGYI-T-20981/04 $ OGYI-T /05 $ OGYI-T-20981/06 $ OGYI-T-20981/07 $ OGYI-T /08 $ OGYI-T-20981/09 $ OGYI-T-20981/10 $ OGYI-T /11 $ OGYI-T-20981/12 $ OGYI-T-20981/13 $ OGYI-T /14 $ OGYI-T-20981/15 $ OGYI-T-20981/16 $ OGYI-T /17 $ OGYI-T-20981/18 $ OGYI-T-20981/19 $ OGYI-T /20 Acarbose Sandoz NL $ NL $ $ $ $ $ Generics [uk] Limited Sandoz Hungary France EMA/98477/2016 Page 5/10
6 National Number Acarbose Stada $ Stadapharm Gmbh Germany Acarbose UK/H/1218/01 $ UK/H/1218/02 PL 20117/0178 $ PL 20117/0179 Morningside Healthcare Ltd United Kingdom Acarbose Zentiva $ $ $ $ $ Sanofi-Aventis France Acarbose-CT $ Abz-Pharma Gmbh, Graf- Arco-Str. 3 France Germany Acarbose-Ratiopharm Ratiopharm Gmbh Germany Acarbose-Ratiopharm Ratiopharm Gmbh Germany Acarbosio TecniGen UK/H/1218/01 $ UK/H/1218/02 Acarphage DE/H/0869/001 $ DE/H/0869/002/DC /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ $ $ $ $ $ $ $ Tecnimede - Sociedade Técnico-Medicinal, Sa Merck Serono S.P.A. Italy Italy EMA/98477/2016 Page 6/10
7 National Number $ $ $ $ Adeksa $ Polfarmex S.A. Poland Akarboza Mylan DE/H/0869/002/DC 18/613/08-C Generics [uk] Limited Czech Republic Glicobase $ Bayer Spa Italy Glucarb PT/H/0662/01-02/DC $ Tarchominskie Zaklady Farmaceutyczne "polfa" Spólka Akcyjna Poland Glucobay $ Bayer Spa Italy Glucobay $ Bayer Austria Gmbh Austria Glucobay $ Bayer Pharma Ag Denmark Glucobay $ Bayer Pharma Ag Finland EMA/98477/2016 Page 7/10
8 National Number Glucobay $ Bayer Pharma Ag Sweden Glucobay Bayer Hellas Sa Cyprus Glucobay 18/061/87-A/C $ 18/061/87-B/C Bayer Pharma Ag Czech Republic Glucobay $ Bayer Sa Nv Luxembourg Glucobay 20727/ $ 20728/ Bayer Hellas Sa Greece Glucobay 5363-I-966/12 $ 5363-I-967/12 Bayer D.O.O Slovenia Glucobay 12/H0063/ , , Centrofarma Lda Glucobay 5553/2005/01-02 $ 5554/2005/01-02 Bayer Pharma Ag Romania Glucobay 13/H0097/ $ $ Centrofarma Lda EMA/98477/2016 Page 8/10
9 National Number Glucobay $ Bayer Hispania Sl Spain Glucobay 8113 $ 8114 Bayer Pharma Ag Norway Glucobay Bayer Pharma Ag Iceland Glucobay Bayer Pharma Ag Iceland Glucobay 1/55/ $ $ $ $ $ Centrofarma Lda Glucobay $ Bayer Vital Gmbh Germany Glucobay BE $ BE Bayer Sa Nv Belgium Glucobay MA513/00901 $ MA513/00902 Bayer Plc Malta Glucobay OGYI-T-1657/01 $ OGYI-T-1657/02 $ OGYI-T-1657/03 $ OGYI-T- 1657/04 $ OGYI-T-1657/05 $ OGYI- T-1657/06 $ OGYI-T-1657/07 $ OGYI-T-1657/08 $ OGYI-T-1657/09 $ OGYI-T-1657/10 $ OGYI-T- Bayer Pharma Ag Hungary EMA/98477/2016 Page 9/10
10 National Number 1657/11 $ OGYI-T-1657/12 Glucobay PA 1410/29/1 $ PA 1410/29/2 Bayer Ltd Ireland Glucobay PL 00010/0171 $ PL 00010/0172 Bayer Plc United Kingdom Glucobay R/2854 $ R/2855 Bayer Pharma Ag Poland Glucobay RVG $ RVG Bayer Bv Netherlands Glucobay UP/I /09-02/554 $ UP/I /09-02/555 Bayer Doo Croatia Glucor NL 19834, NL Bayer HealthCare France Symrose UK/H/1218/ $ Symphar Sp. Z O.O. Poland глюкобай Bayer Pharma Ag Bulgaria EMA/98477/2016 Page 10/10
List of nationally authorised medicinal products
5 November 2015 EMA/230130/2016 Procedure Management and Committees Support Active substance: cabergoline Procedure no.: PSUSA/00000477/201503 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
List of nationally authorised medicinal products
11 February 2016 EMA/255959/2016 Procedure Management and Committees Support Active substance: calcitonin salmon, synthetic analogue of eel calcitonin Procedure No.: PSUSA/00000494/201506 30 Churchill
List of nationally authorised medicinal products
7 July 2016 EMA/437334/2016 Procedure Management and Committees Support Division Active substance: Terazosin Procedure no.: PSUSA/00002895/201511 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
List of nationally authorised medicinal products
10 September 2015 EMA/612853/2015 Procedure Management and Committees Support Active substance: tobramycin (nebuliser solution) Procedure no.: PSUSA/00009316/201412 30 Churchill Place Canary Wharf London
List of nationally authorised medicinal products
10 September 2015 EMA/677092/2015 Procedure Management and Committees Support Active substance: glatiramer Procedure no.: PSUSA/00001529/201411 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
List of nationally authorised medicinal products
29 November 2018 EMA/880324/2018 Human Medicines Evaluation Division Active substance: enalapril Procedure no.: PSUSA/00001211/201803 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
Please note that this draft Annex I will be updated to amend information on concerned products/mahs
22 March 2018 EMA/197481/2018 Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of, applicants, marketing authorisation holders in the member states for for omega-3
List of nationally authorised medicinal products
10 September 2015 EMA/622830/2015 Procedure Management and Committees Support Active substance: azelastine Procedure no.: PSUSA/00000277/201412 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
List of nationally authorised medicinal products
30 November 2017 EMA/817351/2017 Human Medicines Evaluation Division Active substance: Lidocaine / prilocaine (not centrally authorised product) Procedure no.: PSUSA/00001867/201703 30 Churchill Place
List of nationally authorised medicinal products
08 March 2018 EMA/170163/2018 Human Medicines Evaluation Division Active substance: enalapril / hydrochlorothiazide Procedure no.: PSUSA/00001212/201707 30 Churchill Place Canary Wharf London E14 5EU United
List of nationally authorised medicinal products
8 March 2018 EMA/182668/2018 Human Medicines Evaluation Division Active substance(s): triamcinolone (topical and nasal formulations) Procedure No.: PSUSA/00003017/201707 30 Churchill Place Canary Wharf
Member State Marketing autorisation Holder Invented Name Strength Pharmaceutical form Route of administration
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 1 Member State Marketing autorisation Holder
List of nationally authorised medicinal products
01 December 2016 Human Medicines Evaluation Division Active substance: Procedure no.: PSUSA/00002591/201604 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile
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List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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