List of nationally authorised medicinal products
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1 25 January 2017 EMA/173834/2017 Human Medicines Evaluation Division Active substance: Misoprostol (gynaecological indication - labour induction) 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 Authorisation Misofar 25 microgramos comprimidos vaginales not available LABORATORIOS BIAL, S.A. ES Misofar 200 microgramos comprimidos vaginales not available LABORATORIOS BIAL, S.A. ES mikrog depotlääkevalmiste, emättimeen microgram, hulpmiddel voor vaginaal gebruik μικρογραμμάρια σύστημα για ενδοκολπική χορήγηση μικρογραμμάρια σύστημα για ενδοκολπική χορήγηση Misodel 0,2 mg sistema de libertação vaginal. Misodel 0,2 mg sistema de libertação vaginal. SE/H/1224/ FERRING LÄÄKKEET OY FI SE/H/1224/001 RVG FERRING B.V. NL SE/H/1224/ FERRING HELLAS MEPE GR SE/H/1224/ FERRING PHARMACEUTICALS CY A/S SE/H/1224/ FERRING PORTUGUESA PT PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA. SE/H/1224/ FERRING PORTUGUESA PT PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA. for misoprostol (gynaecological indication - labour induction) EMA/173834/2017 Page 2/6
3 National Authorisation Misodel 0,2 mg sistema de libertação vaginal. Mikrogramm vaginales Wirkstofffreisetzungssyst em mikrogramů vaginální inzert SE/H/1224/01/DC FERRING PORTUGUESA PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA. SE/H/1224/ FERRING ARZNEIMITTEL GES.M.B.H. SE/H/1224/001 54/123/14-C FERRING PHARMACEUTICALS CZ S.R.O. PT AT CZ MISODEL 200 Mikrogramm vaginales Wirkstofffreisetzungssyst em mikrogrammi vaginaalravivahend microgramos sistema de liberación vaginal microgrammes, dispositif microgrammes, dispositif SE/H/1224/ FERRING ARZNEIMITTEL GMBH DE SE/H/1224/ FERRING GMBH EE SE/H/1224/ FERRING S.A.U. ES SE/H/1224/ OU FERRING S.A.S. FR 1 5 SE/H/1224/ OU FERRING S.A.S. FR 8 3 EMA/173834/2017EMA/382341/2015 Page 3/6
4 National Authorisation microgrammes, dispositif míkróg skeiðarinnlegg SE/H/1224/ OU FERRING S.A.S. FR 6 5 SE/H/1224/001 IS/1/13/092/01 FERRING LÆGEMIDLER A/S IS mikrogrami vaginālās ievadīšanas sistēma mikrogramų vartojimo į makštį sistema mikrogramu vartojimo i makšti sistema mikrogramu vartojimo i makšti sistema mikrogram vaginalinnlegg SE/H/1224/ FERRING GMBH LV SE/H/1224/001 LT/1/13/3442/001 FERRING GMBH LT SE/H/1224/001 LT/1/13/3442/002 FERRING GMBH LT SE/H/1224/001 LT/1/13/3442/003 FERRING GMBH LT SE/H/1224/ FERRING LEGEMIDLER AS NO Misodel, 200 mikrogramów, system terapeutyczny dopochwowy micrograme sistem cu cedare vaginală SE/H/1224/ FERRING GMBH PL SE/H/1224/ /2014/01 FERRING GMBH RO EMA/173834/2017EMA/382341/2015 Page 4/6
5 National Authorisation mikrogram vaginalinlägg SE/H/1224/ FERRING LÄKEMEDEL AB SE mikrogramov vaginálny inzert SE/H/1224/001 81/0476/13-S FERRING LÉCIVA A.S. SK microgrammes système microgram hulpmiddel voor vaginaal gebruik micrograms Vaginal Delivery System microgrammi dispositivo vaginale microgrammi dispositivo vaginale microgrammi dispositivo vaginale microgrammes système SE/H/1224/001 BE FERRING N.V. BE SE/H/1224/001 BE FERRING N.V. BE SE/H/1224/001 PA 1009/025/001 FERRING IRELAND LTD. IE SE/H/1224/ FERRING S.P.A. IT SE/H/1224/ FERRING S.P.A. IT SE/H/1224/ FERRING S.P.A. IT SE/H/1224/001 BE / FERRING N.V. LU EMA/173834/2017EMA/382341/2015 Page 5/6
6 National Authorisation mikrogramov vaginalni dostavni sistem mikrogramov vaginalni dostavni sistem mikrogramov vaginalni dostavni sistem mikrogramm hüvelyben alkalmazott gyógyszerleadó rendszer Мизодел 200 микрограма вагинална лекарстводоставяща система micrograme sistem cu cedare vaginală SE/H/1224/ I-418/14 FERRING GMBH SI SE/H/1224/ I-419/14 FERRING GMBH SI SE/H/1224/ I-420/14 FERRING GMBH SI SE/H/1224/001 OGYI-T-22575/01 FERRING MAGYARORSZÁG HU GYÓGYSZERKERESKEDELMI KFT. SE/H/1224/ FERRING GMBH BG SE/H/1224/ /2014/02 FERRING GMBH RO micrograme sistem cu cedare vaginală SE/H/1224/ /2014/03 FERRING GMBH RO SE/H/1224/001 PL 03194/0112 FERRING PHARMACEUTICALS UK micrograms vaginal delivery system. LTD. Misodel, vaginalindlæg SE/H/1224/ FERRING LÆGEMIDLER A/S DK EMA/173834/2017EMA/382341/2015 Page 6/6
List of nationally authorised medicinal products
11 January 2018 EMA/11926/2018 Human Medicines Evaluation Division Active substance: misoprostol (gynaecological indication labour induction) Procedure no.: PSUSA/00010353/201705 30 Churchill Place Canary
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14 January 2016 EMA/230198/2016 Procedure Management and Committees Support Active substance: terlipressin Procedure no.: PSUSA/00002905/201504 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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22 July 2015 EMA/586234/2015 Procedure Management and Committees Support Active substance: amiodarone Procedure no.: PSUSA/00000166/201412 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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14 April 2016 EMA/316649/2016 Procedure Management and Committees Support List of nationally authorised medicinal products Active substance(s): olodaterol Procedure No.: PSUSA/00010245/201509 30 Churchill
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27 October 2016 EMA/735253/2016 Procedure Management and Committees Support Active substance: eletriptan Procedure no.: PSUSA/00001204/201602 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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1 September 2017 EMA/578638/2017 Human Medicines Evaluation Division Active substance(s): ursodeoxycholic acid Procedure No.: PSUSA/00003084/201611 30 Churchill Place Canary Wharf London E14 5EU United
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13 September 2017 EMA/699929/2017 Human Medicines Evaluation Division Active substance(s): bendamustine hydrochloride Procedure No.: PSUSA/00003162/201701 30 Churchill Place Canary Wharf London E14 5EU
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24 January 2018 EMA/141276/2018 Human Medicines Evaluation Division Active substance: irinotecan (except for liposomal formulations) Procedure no.: PSUSA/00001783/201705 30 Churchill Place Canary Wharf
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13 September 2017 EMA/695016/2017 Human Medicines Evaluation Division Active substance: roxithromycin Procedure no.: PSUSA/00002669/201612 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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30 November 2017 EMA/806818/2017 Human Medicines Evaluation Division Active substance: pravastatin Procedure no.: PSUSA/00002500/201703 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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