List of nationally authorised medicinal products
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1 13 December 2017 EMA/46884/2018 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance(s): epoprostenol 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 Caripul 0.5 mg Polvere e Solvente per Soluzione per Infusione Caripul 0.5 mg Polvere per Soluzione per Infusione Caripul 1.5 mg Polvere per Soluzione per Infusione Caripul1.5 mg Polvere e Solvente per Soluzione per Infusione Epoprostenol NORMON 1,5 mg polvo para solución para perfusión NL/H/2600/003/DC ACTELION REGISTRATION NL/H/2600/001/DC ACTELION REGISTRATION NL/H/2600/002/DC ACTELION REGISTRATION NL/H/2600/004/DC ACTELION REGISTRATION not available LABORATORIOS NORMON, S.A. Flolan NL/H/2852/ GLAXOSMHKLINE PHARMA A/S Flolan NL/H/2852/001/MR GLAXOSMHKLINE PHARMA A/S Flolan 0,5 mg - Pulver NL/H/2852/003/MR GLAXOSMHKLINE PHARMA GMBH. Flolan 0,5 mg Pulver NL/H/2852/ GLAXOSMHKLINE Flolan 0,5 mg Pulver NL/H/2852/003/MR GLAXOSMHKLINE Flolan 0,5 mg Pulver NL/H/2852/ GLAXOSMHKLINE ES DK DK AT Page 2/10
3 Flolan 0,5 mg Pulver zur Flolan 0,5 mg Pulver zur Flolan 0,5 mg poeder en oplossing voor Flolan 0,5 mg poeder en oplossing voor Flolan 0,5 mg poeder Flolan 0,5 mg poeder FLOLAN 0,5 mg Polvere e Solvente per Soluzione per Infusione FLOLAN 0,5 mg Polvere per soluzione per infusione Flolan 0,5 mg polvo y disolvente para solución para perfusión Flolan 0,5 mg poudre et pour Flolan 0,5 mg poudre et pour Flolan 0,5 mg poudre et NL/H/2852/ GLAXOSMHKLINE NL/H/2852/ GLAXOSMHKLINE NL/H/2852/ GLAXOSMHKLINE NL/H/2852/003/MR GLAXOSMHKLINE NL/H/2852/ GLAXOSMHKLINE NL/H/2852/004 RVG GLAXOSMHKLINE B.V. NL NL/H/2852/003/MR THE WELLCOME FOUNDATION NL/H/2852/ THE WELLCOME FOUNDATION NL/H/2852/ GLAXOSMHKLINE S.A. ES NL/H/2852/003/MR GLAXOSMHKLINE NL/H/2852/ GLAXOSMHKLINE NL/H/2852/ GLAXOSMHKLINE Page 3/10
4 pour Flolan 0,5 mg poudre Flolan 0,5 mg poudre Flolan 0,5 mg pulver og væske til infusjonsvæske, oppløsning Flolan 0,5 mg, poeder en oplossing voor FLOLAN 0,5 mg, poudre et pour Flolan 0,5 mg, prášek a rozpouštědlo pro infuzní roztok Flolan 0.5 mg powder and solvent for solution for infusion Flolan 0.5 mg powder and solvent for solution for infusion Flolan 1,5 mg - Pulver Flolan 1,5 mg Pulver Flolan 1,5 mg Pulver NL/H/2852/ GLAXOSMHKLINE NL/H/2852/ GLAXOSMHKLINE NL/H/2852/ GLAXOSMHKLINE AS NO NL/H/2852/003 RVG GLAXOSMHKLINE B.V. NL NL/H/2852/003 NL22893 LABORATOIRE GLAXOSMHKLINE NL/H/2852/003 83/383/01-C THE WELLCOME FOUNDATION NL/H/2852/003 PA 1077/058/002 GLAXOSMHKLINE (IRELAND) LIMED NL/H/2852/003/MR MA 167/01701 GLAXO WELLCOME UK LIMED NL/H/2852/001/MR GLAXOSMHKLINE PHARMA GMBH. NL/H/2852/001/MR GLAXOSMHKLINE NL/H/2852/ GLAXOSMHKLINE FR CZ IE MT AT Page 4/10
5 Flolan 1,5 mg Pulver Flolan 1,5 mg Pulver zur Flolan 1,5 mg Pulver zur Flolan 1,5 mg poeder en oplossing voor Flolan 1,5 mg poeder en oplossing voor Flolan 1,5 mg poeder Flolan 1,5 mg poudre et pour Flolan 1,5 mg poudre et pour Flolan 1,5 mg poudre et pour Flolan 1,5 mg poudre Flolan 1,5 mg poudre NL/H/2852/001/MR GLAXOSMHKLINE NL/H/2852/002/MR GLAXOSMHKLINE NL/H/2852/002/MR GLAXOSMHKLINE NL/H/2852/001/MR GLAXOSMHKLINE NL/H/2852/001/MR GLAXOSMHKLINE NL/H/2852/002/MR GLAXOSMHKLINE NL/H/2852/001/MR GLAXOSMHKLINE L/H/2852/001/MR GLAXOSMHKLINE NL/H/2852/001/MR 2003/ GLAXOSMHKLINE NL/H/2852/002/MR GLAXOSMHKLINE NL/H/2852/002/MR GLAXOSMHKLINE Page 5/10
6 Flolan 1,5 mg pulver og NL/H/2852/001/MR GLAXOSMHKLINE AS NO væske til infusjonsvæske, oppløsning Flolan 1,5 mg, poeder en NL/H/2852/001/MR RVG GLAXOSMHKLINE B.V. NL oplossing voor Flolan 1,5 mg, poeder NL/H/2852/002/MR RVG GLAXOSMHKLINE B.V. NL FLOLAN 1,5 mg, poudre et pour NL/H/2852/001/MR NL22894 LABORATOIRE GLAXOSMHKLINE FR Flolan 1,5 mg, prášek a NL/H/2852/001/MR 83/384/01-C THE WELLCOME CZ rozpouštědlo pro infuzní FOUNDATION roztok FLOLAN 1,5 mg/50 ml NL/H/2852/001/MR THE WELLCOME Polvere e solvente per FOUNDATION soluzione per infusione Flolan 1.5 mg powder NL/H/2852/001/MR PA 1077/058/001 GLAXOSMHKLINE IE and solvent for solution for infusion (IRELAND) LIMED Flolan, 0,5 milligrammi NL/H/2852/ GLAXO WELLCOME EE infusioonilahuse pulber ja lahusti Flolan 0.5 mg powder NL/H/2852/004 PL 10949/0310 GLAXO WELLCOME UK UK and solvent for solution TRADING AS for infusion GLAXOSMHKLINE UK Flolan 1.5 mg powder NL/H/2852/002/MR PL10949/0312 GLAXO WELLCOME UK UK and solvent for solution TRADING AS for infusion GLAXOSMHKLINE UK VELETRI 0,5 mg poudre NL/H/2723/001/E/ ACTELION REGISTRATION VELETRI 0,5 mg proszek NL/H/2600/ ACTELION REGISTRATION PL Page 6/10
7 i rozpuszczalnik do sporządzania roztworu do infuzji VELETRI 0,5 mg Pulver NL/H/2723/001/E/ ACTELION REGISTRATION zur VELETRI 0,5 mg, poudre NL/H/2723/ ACTELION REGISTRATION Veletri 0.5 mg Pó e NL/H/2600/003/DC NL/H/260/03/DC ACTELION REGISTRATION PT Solvente para Solução para Perfusão Veletri 0.5 mg Pó para NL/H/2600/001/DC ACTELION REGISTRATION PT Solução para Perfusão Veletri 0.5 mg poeder en NL/H/2600/003/DC RVG ACTELION REGISTRATION NL oplossing voor Veletri 0.5 mg poeder NL/H/2600/001/DC RVG ACTELION REGISTRATION NL Veletri 0.5 mg poeder NL/H/2723/001/DC RVG ACTELION REGISTRATION NL Veletri 0.5 mg polvo para NL/H/2723/001/DC ACTELION REGISTRATION ES solución para perfusión Veletri 0.5 mg por NL/H/2723/001/E/001 OGYI-T-23058/01 ACTELION REGISTRATION HU oldatos infúzióhoz Veletri 0.5 mg poudre et NL/H/2600/003/DC , ACTELION REGISTRATION FR pour Veletri 0.5 mg poudre NL/H/2600/001/DC , ACTELION REGISTRATION FR Veletri 0.5 mg Powder NL/H/2723/001/E/001 PA 2094/001/001 ACTELION REGISTRATION IE for Solution for Infusion Veletri 0.5 mg POWDER NL/H/2600/001/DC PL 18900/0007 ACTELION REGISTRATION UK Page 7/10
8 FOR SOTION FOR INFUSION Veletri 0.5 mg prášek NL/H/2600/001/DC 83/361/13-C ACTELION REGISTRATION CZ pro infuzní roztok Veletri 0.5 mg prášok na NL/H/2723/001/E/001 16/0397/16-S ACTELION REGISTRATION SK infúzny roztok Veletri 0.5 mg proszek NL/H/2600/001/DC ACTELION REGISTRATION PL do sporządzania roztworu do infuzji Veletri 0.5 mg Pulver zur NL/H/2723/001/E/ ACTELION REGISTRATION DE Veletri 0.5 mg κόνις για NL/H/2723/001/E/ ACTELION REGISTRATION GR διάλυμα προς έγχυση VELETRI 1,5 mg proszek NL/H/2600/ ACTELION REGISTRATION PL i rozpuszczalnik do sporządzania roztworu do infuzji VELETRI 1,5 mg Pulver NL/H/2723/002/E/ ACTELION REGISTRATION zur VELETRI 1,5 mg, poudre NL/H/2723/ ACTELION REGISTRATION VELETRI 1,5 mg, poudre NL/H/2723/002/E/ ACTELION REGISTRATION Veletri 1.5 mg Pó e NL/H/2600/004/DC NL/H/2600/004/DC ACTELION REGISTRATION PT Solvente para Solução para Perfusão Veletri 1.5 mg Pó para NL/H/2600/002/DC ACTELION REGISTRATION PT Solução para Perfusão Veletri 1.5 mg poeder en NL/H/2600/004/DC RVG ACTELION REGISTRATION NL oplossing voor Veletri 1.5 mg poeder NL/H/2600/002/DC RVG ACTELION REGISTRATION NL Page 8/10
9 Veletri 1.5 mg poeder Veletri 1.5 mg polvo para solución para perfusión Veletri 1.5 mg por oldatos infúzióhoz Veletri 1.5 mg poudre et pour Veletri 1.5 mg poudre Veletri 1.5 mg Powder for Solution for Infusion Veletri 1.5 mg POWDER FOR SOTION FOR INFUSION Veletri 1.5 mg prášek pro infuzní roztok Veletri 1.5 mg prášok na infúzny roztok Veletri 1.5 mg proszek do sporządzania roztworu do infuzji Veletri 1.5 mg Pulver zur Veletri 1.5 mg κόνις για διάλυμα προς έγχυση NL/H/2723/002/DC RVG ACTELION REGISTRATION NL/H/2723/002/DC ACTELION REGISTRATION NL/H/2723/002/E/001 OGYI-T-23058/02 ACTELION REGISTRATION NL/H/2600/004/DC , ACTELION REGISTRATION NL/H/2600/002/DC , ACTELION REGISTRATION NL/H/2723/002/E/001 PA 2094/001/002 ACTELION REGISTRATION NL/H/2600/002/DC PL 18900/0008 ACTELION REGISTRATION NL/H/2600/002/DC 83/362/13-C ACTELION REGISTRATION NL/H/2723/002/E/001 16/0398/16-S ACTELION REGISTRATION NL/H/2600/002/DC ACTELION REGISTRATION NL/H/2723/002/E/ ACTELION REGISTRATION NL/H/2723/002/E/ ACTELION REGISTRATION NL ES HU FR FR IE UK CZ SK PL DE GR Page 9/10
10 Page 10/10
List of nationally authorised medicinal products
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