List of nationally authorised medicinal products
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1 14 January 2016 EMA/230198/2016 Procedure Management and Committees Support Active substance: terlipressin 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) MRP/DCP Authorisation number National Authorisation Number MAH of product in the member state Glipressina Ferring S.P.A. Italy Glipressina Ferring S.P.A. Italy Glycylpressin Ferring Arzneimittel Austria Glycylpressin Ferring Arzneimittel Austria Glycylpressin Ferring Gmbh Germany Glycylpressin Ferring Gmbh Germany Glypressin Ferring Lääkkeet Oy Finland Member State where product is authorised Glypressin Ferring N.V. Luxembourg Glypressin DK/H/0829/ Ferring Hellas Mepe Cyprus Glypressin Ferring Lääkkeet Oy Finland Glypressin Ferring S.A.S. France Glypressin DK/H/0829/ Ferring Lægemidler A/S Denmark Glypressin Ferring S.A.U. Spain Glypressin Ferring S.A.U. Spain Glypressin 7539/2006/01 Ferring Gmbh Romania Glypressin (IS) Ferring Lægemidler A/S Iceland Glypressin BE Ferring N.V. Belgium Glypressin 0349/ Ferring N.V. Luxembourg Glypressin BE Ferring N.V. Belgium Glypressin DK/H/0829/002 H/05/00711/001 Ferring Gmbh Slovenia EMA/230198/2016 Page 2/5
3 Glypressin DK/H/0829/ I-762/08 Ferring Arzneimittel Slovenia Glypressin HR-H Ferring Gmbh Croatia Glypressin IS/1/10/101/01 Ferring Lægemidler A/S Iceland Glypressin OGYI-T-7887/01 $ OGYI-T-7887/02 Ferring Magyarország Hungary Gyógyszerkereskedelmi Kft. Glypressin OGYI-T-7887/03 Ferring Magyarország Hungary Gyógyszerkereskedelmi Kft. Glypressin PA 1009/4/1 Ferring Ireland Ltd. Ireland Glypressin PA 1009/4/2 Ferring Ireland Ltd. Ireland Glypressin PL 03194/0018 Ferring Pharmaceuticals Ltd. United Kingdom Glypressin PL 03194/0101 Ferring Pharmaceuticals Ltd. United Kingdom Glypressin RVG Ferring B.V. Netherlands Glypressin DK/H/0829/ Ferring Lääkkeet Oy Latvia Glypressin DK/H/0829/ Ferring Gmbh Poland Glypressin DK/H/0829/ Ferring Lægemidler A/S Denmark Glypressin DK/H/0829/ Ferring Hellas Mepe Cyprus Glypressin DK/H/0829/ Ferring Läkemedel Ab Sweden Glypressin DK/H/0829/ Ferring Lääkkeet Oy Estonia Glypressin DK/H/0829/ / Ferring Hellas Mepe Greece Glypressin DK/H/0829/001 84/393/05-C Ferring Léciva A.S. Czech Republic Glypressin DK/H/0829/001 LT/1/05/0470/001 Ferring Lääkkeet Oy Lithuania Glypressin DK/H/0829/001 MA832/00701 Ferring Pharmaceuticals Ltd. Malta EMA/230198/2016 Page 3/5
4 Glypressin DK/H/0829/001 $ $ Ferring Legemidler As Norway DK/H/0829/002 Glypressin DK/H/0829/ Ferring Lääkkeet Oy Latvia Glypressin DK/H/0829/ Ferring Gmbh Poland Glypressin DK/H/0829/ / Ferring Hellas Mepe Greece Glypressin DK/H/0829/ Ferring Läkemedel Ab Sweden Glypressin DK/H/0829/ Ferring Lääkkeet Oy Estonia Glypressin DK/H/0829/002 84/0874/10-S Ferring Léciva A.S. Slovakia Glypressin DK/H/0829/002 84/849/10-C Ferring Léciva A.S. Czech Republic Glypressin DK/H/0829/002 LT/1/05/0470/002 Ferring Lääkkeet Oy Lithuania Glypressin DK/H/0829/002 MA832/00702 Ferring Pharmaceuticals Ltd. Malta Glypressin DK/H/829/001 84/0314/05-S Ferring Léciva A.S. Slovakia Glypressine $ Ferring Portuguesa Portugal Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Glypressine Ferring Portuguesa Portugal Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Glypressine Ferring S.A.S. France Remestyp 84/0102/78-CS Ferring Léciva A.S. Slovakia Remestyp 84/102/78-C $ 84/110/98-C Ferring Léciva A.S. Czech Republic Remestyp Ferring Gmbh Bulgaria Remestyp R/0999 Ferring Léciva A.S. Poland Stemflova NL/H/2566/ Is Pharmaceuticals Limited Italy EMA/230198/2016 Page 4/5
5 Variquel DE/H/1201/ Is Pharmaceuticals Limited Finland Variquel NL/H/2566/ Is Pharmaceuticals Limited Germany Variquel NL/H/2566/ Is Pharmaceuticals Limited Luxembourg Variquel NL/H/2566/ Is Pharmaceuticals Limited France Variquel NL/H/2566/ Is Pharmaceuticals Limited Sweden Variquel NL/H/2566/ Is Pharmaceuticals Limited Denmark Variquel NL/H/2566/ Is Pharmaceuticals Limited Portugal Variquel NL/H/2566/ Is Pharmaceuticals Limited Spain Variquel NL/H/2566/001 BE Is Pharmaceuticals Limited Belgium Variquel NL/H/2566/001 PA 1530/002/001 Is Pharmaceuticals Limited Ireland Variquel NL/H/2566/001 PL 13538/0021 Is Pharmaceuticals Limited United Kingdom Variquel Oplossing NL/H/2566/001 RVG Is Pharmaceuticals Limited Netherlands EMA/230198/2016 Page 5/5
List of nationally authorised medicinal products
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