1 September 2017 EMA/578102/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): tibolone
Procedure No.: PSUSA/00002947/201612
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
Boltin 2,5 mg comprimidos
not available
60.100
Boltin 2,5 mg comprimidos LIVIAL 2,5 mg compresse Livial 2,5 mg comprimidos Livial 2,5 mg comprimidos Livial 2,5 mg tablete Livial 2,5 mg tablete Livial 2,5 mg tabletes Livial 2,5 mg tabletės Livial 2,5 mg tablett Livial 2,5 mg tabletta Livial 2,5 mg tabletta Livial 2,5 mg tabletter Livial 2,5 mg tabletter Livial 2,5 mg tabletti Livial 2,5 mg töflur Livial 2,5 mg δισκία LIVIAL 2,5 mg, comprimé LIVIAL 2,5 mg, comprimé LIVIAL 2,5 mg, comprimé LIVIAL 2,5 mg, comprimé Livial 2,5 mg, tablety Livial 2.5 mg tablets Livial 2.5 mg tablets LIVIAL 2.5mg Tablets Livial, 2,5 mg tabletid Livial, 2,5 mg tabletten Livial, 2,5 mg, tabletki Livial, tabletter Livial, tabletter Livial® 2,5 mg comprimés Livial® 2,5 mg tabletten Livial® 2.5 mg tablets LIVIAL® 2,5 mg tablety
not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available
60.100 028035018 8777318 8777300 H/98/00931/001 H/98/00931/001 98-0299 LT/1/98/2570/001 11701 OGYI-T-20953/01 OGYI-T-20953/02 95-3901 13115 11701 950170 43544/18-09-2009 354 358-6 360 942-8 354 359-2 360 943-4 54/0249/91-C/S 13428 MA058/03201 PA 0964/006/001 275599 RVG 11146 R/1580 12136 12136 2011041112 BE158593 PL 00025/0599
MERCK SHARP & DOHME DE ESPAÑA, S.A MERCK SHARP & DOHME DE ESPAÑA, S.A NV ORGANON MERCK SHARP & DOHME, LDA. MERCK SHARP & DOHME, LDA. NV ORGANON NV ORGANON NV ORGANON NV ORGANON MERCK SHARP & DOHME BV MSD PHARMA HUNGARY KFT. MSD PHARMA HUNGARY KFT. MERCK SHARP & DOHME BV MERCK SHARP & DOHME BV MERCK SHARP & DOHME BV MERCK SHARP & DOHME BV MSD GREECE MSD FRANCE MSD FRANCE MSD FRANCE MSD FRANCE NV ORGANON NV ORGANON MERCK SHARP & DOHME LTD. NV ORGANON NV ORGANON NV ORGANON NV ORGANON MERCK SHARP & DOHME BV MERCK SHARP & DOHME BV MSD BELGIUM BVBA/SPRL MSD BELGIUM BVBA/SPRL MERCK SHARP & DOHME LTD.
not available
54/249/91-C
NV ORGANON
List of nationally authorised medicinal products EMA/578102/2017
MAH of product in the member state
Member State where product is authorised
ES ES IT PT PT SI SI LV LT FI HU HU NO SE FI IS GR FR FR FR FR SK CY MT IE EE NL PL DK DK LU BE UK CZ Page 2/3
Product Name (in authorisation country)
LIVIAL® 2,5 mg tablety
Liviel – Tabletten Liviella 2,5 mg Tabletten Tibolon, 2,5 mg tabletten Ливиал 2,5 mg таблетки
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
54/249/91-C
CZ
not available
1-20657
NV ORGANON MERCK SHARP & DOHME GES.M.B.H.
not available not available not available
33692.00.00 RVG 11146 20000198
MSD SHARP & DOHME GMBH NV ORGANON NV ORGANON
DE NL BG
List of nationally authorised medicinal products EMA/578102/2017
AT
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