List of nationally authorised medicinal products
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1 5 November 2015 EMA/230130/2016 Procedure Management and Committees Support Active substance: cabergoline 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 Product Name (in authorisation country) P/P Authorisation number National Authorisation Number MAH of product in the member state Actualene $ $ Pfizer Italia S.R.L Cabarsuss SE/H/0900/ Hexal A/S Sweden Cabarsuss SE/H/0900/002 $ $ Hexal A/S Sweden SE/H/0900/003 Cabarsuss SE/H/0900/ Hexal A/S Sweden Cabaser $ Pfizer Italia S.R.L. Cabaser Pfizer Oy Finland Cabaser $ Pfizer Ab Sweden Cabaser $ Pfizer Aps Denmark Cabaser $ Pfizer As Norway Cabaser PA 822/114/1 $ PA 822/114/2 Pfizer Healthcare Ireland Ireland Member State where product is authorised Cabaser PL 00057/0936 $ PL 00057/0937 Pfizer Limited United Kingdom Cabaseril $ Pfizer Corporation Austria Austria Gesellschaft M.B.H. Cabaseril $ Pharmacia Gmbh Germany Cabergolin 1 A Pharma SE/H/0901/ A Pharma Gmbh Germany Cabergolin 1 A Pharma SE/H/0901/ A Pharma Gmbh Germany Cabergolin 1 A Pharma SE/H/0901/ A Pharma Gmbh Germany Cabergolin Dura DE/H/1964/001 $ DE/H/1964/002 $ DE/H/1964/003 Cabergolin Hexal SE/H/0650/001 $ SE/H/0900/ $ $ Mylan Dura Gmbh Germany $ Hexal Ag Germany EMA/230130/2016 Page 2/8
3 Cabergolin Hexal SE/H/0650/002 $ SE/H/0650/003 $ SE/H/0900/002 $ SE/H/0900/ $ $ $ Hexal Ag Germany Cabergolin Hexal SE/H/0651/ Hexal A/S Denmark Cabergolin Hexal SE/H/0900/ Hexal Ag Germany Cabergolin Hexal SE/H/0901/ A Pharma Gmbh Germany Cabergolin Teva DK-H Teva Denmark A/S Denmark Cabergolin Teva DK-H $ Teva Denmark A/S Denmark Cabergolin-Teva SE-H Teva Gmbh Germany Cabergolin-Teva SE-H $ Teva Gmbh Germany Cabergolina Ratiopharm SE-H $ Ratiopharm Gmbh Cabergolina Ratiopharm SE-H $ /M $ Cabergolina Sandoz SE/H/0651/ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M Ratiopharm Gmbh Sandoz S.P.A. EMA/230130/2016 Page 3/8
4 Cabergolina Sandoz SE/H/0651/002 $ SE/H/0651/003 Cabergolina Sandoz Gmbh Cabergolina Sandoz Gmbh Cabergolina Teva Cabergolina Teva Cabergoline Cabergoline $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M $ /M SE/H/0899/ $ $ $ $ SE/H/0899/002 $ SE/H/0899/003 DK-H DK-H UK-H UK-H Sandoz S.P.A. Sandoz Gmbh $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ Sandoz Gmbh Teva Pharma S.L.U. Spain $ Teva Pharma S.L.U. Spain PL 00289/0988 Teva Uk Limited United Kingdom PL 00289/0989 $ PL 00289/0990 Teva Uk Limited United Kingdom EMA/230130/2016 Page 4/8
5 Cabergoline "sandoz" SE/H/0899/ Sandoz A/S Denmark Cabergoline 0.5 Pch SE-H RVG Pharmachemie B.V. Netherlands Cabergoline 1a Farma SE/H/0901/ a Farma A/S Sweden Cabergoline 1a Farma SE/H/0901/002 $ $ a Farma A/S Sweden SE/H/0901/003 Cabergoline 1a Farma SE/H/0901/ a Farma A/S Sweden Cabergoline Actavis UK/H/0955/ PL 30306/0594 $ PL 30306/0595 $ Actavis Group Ptc Ehf. United Kingdom Group Ptc Ehf. PL 30306/0596 Cabergoline Aurobindo UK/H/0955/001 RVG Aurobindo Pharma B.V. Netherlands Cabergoline Ct SE-H $ Abz-Pharma Gmbh Germany Cabergoline Hexal SE/H/0650/ Hexal A/S Sweden Cabergoline Hexal SE/H/0650/002 $ $ Hexal A/S Sweden SE/H/0650/003 Cabergoline Ratiopharm SE-H /M Ratiopharm Gmbh Cabergoline Ratiopharm SE-H /M Ratiopharm Gmbh Cabergoline Ratiopharm SE-H Ratiopharm Gmbh Sweden Cabergoline Ratiopharm SE-H Ratiopharm Gmbh Germany Cabergoline Ratiopharm SE-H $ $ Ratiopharm Gmbh Sweden SE-H Cabergoline Ratiopharm SE-H $ $ Ratiopharm Gmbh Germany SE-H Cabergoline Sandoz SE/H/0899/001 RVG Sandoz B.V. Netherlands Cabergoline Sandoz SE/H/0899/ $ Sandoz France 4 1 $ $ $ Cabergoline Sandoz SE/H/0899/ Sandoz A/S Sweden Cabergoline Sandoz SE/H/0899/002 $ SE/H/0899/ $ Sandoz A/S Sweden EMA/230130/2016 Page 5/8
6 Cabergoline Teva DK-H NL32890 Teva Santé France Cabergoline Teva SE-H $ Teva Pharma Belgium N.V. Luxembourg Cabergoline Teva SE-H Teva Sweden Ab Sweden Cabergoline Teva SE-H $ Teva Sweden Ab Sweden Cabergoline Teva SE-H Teva Pharma Belgium N.V. Luxembourg Cabergoline Teva SE-H BE Teva Pharma Belgium N.V. Belgium Cabergoline Teva SE-H BE $ BE Teva Pharma Belgium N.V. Belgium Cabergoline Teva UK-H MA615/01501 Teva Pharma B.V. Malta Cabergoline Teva UK-H MA615/01502 Teva Pharma B.V. Malta Cabergoline Teva UK-H MA615/01503 Teva Pharma B.V. Malta Cabergoline Teva UK-H $ $ Teva Pharma B.V. Cyprus Cabergoline Teva Pharma SE-H $ Teva Pharma B.V. Sweden Cabergonicht SE/H/0651/ Sandoz A/S Sweden Cabergonicht SE/H/0651/002 $ $ Sandoz A/S Sweden SE/H/0651/003 Cabest SE-H /0500/06-S Teva Pharmaceuticals Slovakia Slovakia S.R.O Dostinex $ $ Pfizer Italia S.R.L Dostinex Pfizer Italia S.R.L. Latvia Dostinex Pfizer Corporation Austria Austria Gesellschaft M.B.H. Dostinex Pfizer Oy Finland Dostinex Pfizer Ab Sweden EMA/230130/2016 Page 6/8
7 Dostinex Pfizer Aps Denmark Dostinex Pfizer S.A. (Belgium) Luxembourg Dostinex $ $ Laboratórios Pfizer, Lda. Portugal Dostinex Pharmacia Gmbh Germany Dostinex 44396/ Pfizer Hellas, A.E. Greece Dostinex 4863 Pfizer Europe Ma Eeig Poland Dostinex 54/277/96-C Pfizer, Spol. S R.O. Czech Republic Dostinex Pfizer, S.L. Spain Dostinex 7619/2006/01 $ 7619/2006/02 Pfizer Europe Ma Eeig Romania Dostinex 7843 Pfizer As Norway Dostinex (IS) Pfizer Aps Iceland Dostinex BE Pfizer S.A. (Belgium) Belgium Dostinex LT/1/01/1619/001 $ Pfizer Italia S.R.L. Lithuania LT/1/01/1619/002 $ LT/1/01/1619/003 Dostinex MA505/01401 Pfizer Hellas S.A. Malta Dostinex PA 822/126/1 Pfizer Healthcare Ireland Ireland Dostinex PL 00057/0969 Pfizer Limited United Kingdom Dostinex RVG Pfizer B.V. Netherlands Dostinex S00641 Pfizer Hellas, A.E. Cyprus Dostinex NL Pfizer Holding France France (S.C.A.) Sogilen $ Pfizer, S.L. Spain EMA/230130/2016 Page 7/8
8 Sostilar Pfizer S.A. (Belgium) Luxembourg Sostilar BE Pfizer S.A. (Belgium) Belgium достинекс Pfizer Enterprises Sarl Bulgaria EMA/230130/2016 Page 8/8
List of nationally authorised medicinal products
3 December 2015 EMA/98477/2016 Procedure Management and Committees Support Active substance: acarbose Procedure no.: PSUSA/00000017/201503 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
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
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
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/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
List of nationally authorised medicinal products
27 October 2016 EMA/719205/2016 Human Medicines Evaluation Division Active substance: ethinylestradiol / gestodene (except for transdermal application) Procedure no.: PSUSA/00001308/201603 30 Churchill
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List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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