List of nationally authorised medicinal products

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1 11 January 2018 EMA/11926/2018 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 Product Name (in authorisation country) MRP/DCP Authorisation number National Authorisation Number MAH of product in the member state Angusta, tabletter DK/H/2584/ AZANTA DANMARK A/S DK Angusta 25 mikrogram DK/H/2584/ AZANTA DANMARK A/S NO tabletter Angusta 25 míkróg töflur DK/H/2584/001 IS/1/16/104/01 AZANTA DANMARK A/S IS Member State where product is authorised Angusta 25 mikrog tabletit Angusta 25 mikrogram tabletter mikrog depotlääkevalmiste, emättimeen microgram, hulpmiddel voor vaginaal gebruik μικρογραμμάρια σύστημα για ενδοκολπική χορήγηση μικρογραμμάρια σύστημα για ενδοκολπική χορήγηση DK/H/2584/001/DC AZANTA FI DK/H/2584/ AZANTA DANMARK A/S SE 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 A/S SE/H/1224/ FERRING PORTUGUESA SE/H/1224/ FERRING PORTUGUESA SE/H/1224/ FERRING PORTUGUESA CY EMA/11926/2018 Page 2/5

3 Mikrogramm s Wirkstofffreisetzungssyst em mikrogramů vaginální inzert MISODEL 200 Mikrogramm s Wirkstofffreisetzungssyst em mikrogrammi vaginaalravivahend microgramos de liberación vaginal míkróg skeiðarinnlegg mikrogrami vaginālās ievadīšanas sistēma mikrogramų vartojimo į makštį mikrogramų vartojimo į makštį mikrogramu vartojimo i makšti SE/H/1224/ FERRING ARZNEIMITTEL GES.M.B.H. SE/H/1224/001 54/123/14-C FERRING PHARMACEUTICALS CZ S.R.O. SE/H/1224/ FERRING ARZNEIMITTEL GMBH SE/H/1224/ FERRING GMBH EE SE/H/1224/ FERRING S.A.U. ES SE/H/1224/ OU FERRING S.A.S. FR SE/H/1224/ OU FERRING S.A.S. FR SE/H/1224/ OU FERRING S.A.S. FR SE/H/1224/001 IS/1/13/092/01 FERRING LÆGEMIDLER A/S IS 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 AT CZ DE EMA/11926/2018 Page 3/5

4 mikrogram vaginalinnlegg Misodel, 200 mikrogramów, system terapeutyczny dopochwowy micrograme mikrogram vaginalinlägg mikrogramov vaginálny inzert microgrammes système microgram hulpmiddel voor vaginaal gebruik micrograms Vaginal Delivery System microgrammes système SE/H/1224/ FERRING LEGEMIDLER AS NO SE/H/1224/ FERRING GMBH PL SE/H/1224/ /2014/01 FERRING GMBH RO SE/H/1224/ FERRING LÄKEMEDEL AB SE SE/H/1224/001 81/0476/13-S FERRING LÉCIVA A.S. SK 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/ FERRING N.V. LU SE/H/1224/ I-418/14 FERRING GMBH SI SE/H/1224/ I-419/14 FERRING GMBH SI EMA/11926/2018 Page 4/5

5 mikrogramm hüvelyben alkalmazott gyógyszerleadó rendszer Мизодел 200 микрограма вагинална лекарстводоставяща система micrograme micrograme mikrogram vaginalinlägg micrograms vaginal delivery system. SE/H/1224/ I-420/14 FERRING GMBH SI SE/H/1224/001 OGYI-T-22575/01 FERRING MAGYARORSZÁG GYÓGYSZERKERESKEDELMI KFT. HU SE/H/1224/ FERRING GMBH BG SE/H/1224/ /2014/02 FERRING GMBH RO SE/H/1224/ /2014/03 FERRING GMBH RO SE/H/1224/ FERRING LÄÄKKEET OY FI SE/H/1224/001 PL 03194/0112 FERRING PHARMACEUTICALS LTD. Misodel, vaginalindlæg SE/H/1224/ FERRING LÆGEMIDLER A/S DK UK Misofar 25 microgramos comprimidos s Misofar 200 microgramos comprimidos s not available LABORATORIOS BIAL, S.A. ES not available LABORATORIOS BIAL, S.A. ES EMA/11926/2018 Page 5/5

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