List of nationally authorised medicinal products
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1 9 July 2015 EMA/483529/2015 Procedure Management and Committees Support Active substance: dapoxetine 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 Priligy SE/H/0718/ Berlin-Chemie Ag Austria Priligy SE/H/0718/ Berlin-Chemie Ag Austria Priligy SE/H/0718/001 BE S. Benelux N.V. Belgium Priligy SE/H/0718/002 BE S. Benelux N.V. Belgium Priligy SE/H/718/ M Berlin-Chemie Ag Bulgaria Priligy SE/H/0718/001 UP/I /12-01/523 Berlin-Chemie Ag Croatia Priligy SE/H/0718/002 UP/I /12-01/524 Berlin-Chemie Ag Croatia Priligy SE/H/718/ Pharmaceutical S.A Cyprus Priligy SE/H/718/ Pharmaceutical S.A Cyprus Priligy SE/H/718/001 87/315/12-C Berlin-Chemie Ag Cyprus Priligy SE/H/718/002 87/316/12-C Berlin-Chemie Ag Cyprus Priligy SE/H/0718/ Berlin-Chemie Ag Denmark Priligy SE/H/0718/ Berlin-Chemie Ag Denmark Priligy SE/H/0718/ Berlin-Chemie Ag Estonia Priligy SE/H/0718/ Berlin-Chemie Ag Estonia Priligy SE/H/718/ Berlin-Chemie Ag Finland Priligy SE/H/718/ Berlin-Chemie Ag Finland Priligy SE/H/0718/ Menarini France France Priligy SE/H/0718/ Menarini France France Priligy SE/H/718/ Menarini France France Priligy SE/H/718/ Menarini France France Priligy SE/H/718/ Menarini France France Priligy SE/H/718/ Menarini France France Priligy SE/H/718/ Menarini France France Priligy SE/H/718/ Menarini France France Priligy SE/H/0718/ Berlin-Chemie Ag Germany Member State where product is authorised EMA/483529/2015 Page 2/6
3 Priligy SE/H/0718/ Berlin-Chemie Ag Germany Priligy SE/H/718/ Pharmaceutical S.A Greece Priligy SE/H/718/ Pharmaceutical S.A Greece Priligy SE/H/0718/001 OGYI-T-22140/01 Berlin-Chemie Ag Hungary Priligy SE/H/0718/001 OGYI-T-22140/02 Berlin-Chemie Ag Hungary Priligy SE/H/0718/001 OGYI-T-22140/03 Berlin-Chemie Ag Hungary Priligy SE/H/0718/001 OGYI-T-22140/04 Berlin-Chemie Ag Hungary Priligy SE/H/0718/002 OGYI-T-22140/05 Berlin-Chemie Ag Hungary Priligy SE/H/0718/002 OGYI-T-22140/06 Berlin-Chemie Ag Hungary Priligy SE/H/0718/002 OGYI-T-22140/07 Berlin-Chemie Ag Hungary Priligy SE/H/0718/002 OGYI-T-22140/08 Berlin-Chemie Ag Hungary Priligy SE/H/0718/001 IS/1/12/012/01 Berlin-Chemie Ag Iceland Priligy SE/H/0718/002 IS/1/12/012/02 Berlin-Chemie Ag Iceland Priligy SE/H/0718/001 PA 1833/1/1 Ireland Limited Ireland Priligy SE/H/0718/002 PA 1833/1/2 Ireland Limited Ireland Priligy SE/H/0718/ Priligy SE/H/0718/ Priligy SE/H/0718/ Priligy SE/H/0718/ Italy EMA/483529/2015 Page 3/6
4 Riunite - S.R.L. Priligy SE/H/0718/ Priligy SE/H/0718/ Priligy SE/H/0718/ Priligy SE/H/0718/ Priligy SE/H/718/ Berlin-Chemie Ag Latvia Priligy SE/H/718/ Berlin-Chemie Ag Latvia Priligy SE/H/0718/001 LT/1/12/2920/001 Berlin-Chemie Ag Lithuania Priligy SE/H/0718/001 LT/1/12/2920/002 Berlin-Chemie Ag Lithuania Priligy SE/H/0718/001 LT/1/12/2920/003 Berlin-Chemie Ag Lithuania Priligy SE/H/0718/001 LT/1/12/2920/004 Berlin-Chemie Ag Lithuania Priligy SE/H/0718/002 LT/1/12/2920/005 Berlin-Chemie Ag Lithuania Priligy SE/H/0718/002 LT/1/12/2920/006 Berlin-Chemie Ag Lithuania Priligy SE/H/0718/002 LT/1/12/2920/007 Berlin-Chemie Ag Lithuania Priligy SE/H/0718/002 LT/1/12/2920/008 Berlin-Chemie Ag Lithuania Priligy SE/H/0718/ S. Benelux N.V. Luxembourg Priligy SE/H/0718/ S. Benelux N.V. Luxembourg Priligy SE/H/0718/001 MA1022/00101 Ireland Limited Malta EMA/483529/2015 Page 4/6
5 Priligy SE/H/0718/002 MA1022/00102 Priligy SE/H/0718/001 RVG Priligy SE/H/0718/002 RVG Ireland Limited S. Benelux N.V. S. Benelux N.V. Malta Netherlands Netherlands Priligy SE/H/0718/ Berlin-Chemie Ag Norway Priligy SE/H/0718/ Berlin-Chemie Ag Norway Priligy SE/H/0718/ Berlin-Chemie Ag Poland Priligy SE/H/0718/ Berlin-Chemie Ag Poland Priligy SE/H/0718/ Priligy SE/H/0718/ Priligy SE/H/0718/ Priligy SE/H/0718/ Priligy SE/H/0718/ /2012/01 Berlin-Chemie Ag Romania Priligy SE/H/0718/ /2012/02 Berlin-Chemie Ag Romania Priligy SE/H/0718/ /2012/03 Berlin-Chemie Ag Romania Priligy SE/H/0718/ /2012/04 Berlin-Chemie Ag Romania Priligy SE/H/0718/ /2012/01 Berlin-Chemie Ag Romania Priligy SE/H/0718/ /2012/02 Berlin-Chemie Ag Romania Priligy SE/H/0718/ /2012/03 Berlin-Chemie Ag Romania Priligy SE/H/0718/ /2012/04 Berlin-Chemie Ag Romania Priligy SE/H/0718/001 87/0117/12-S Berlin-Chemie Ag Slovakia Priligy SE/H/0718/002 87/0118/12-S Berlin-Chemie Ag Slovakia Priligy SE/H/718/ I-774/14 Berlin-Chemie Ag Slovenia EMA/483529/2015 Page 5/6
6 Priligy SE/H/718/ I-775/14 Berlin-Chemie Ag Slovenia Priligy SE/H/718/ I-776/14 Berlin-Chemie Ag Slovenia Priligy SE/H/718/ I-777/14 Berlin-Chemie Ag Slovenia Priligy SE/H/718/ I-778/14 Berlin-Chemie Ag Slovenia Priligy SE/H/718/ I-779/14 Berlin-Chemie Ag Slovenia Priligy SE/H/0718/ Laboratorios Menarini, S.A. Spain Priligy SE/H/0718/ Laboratorios Menarini, S.A. Spain Priligy SE/H/0718/ Berlin-Chemie Ag Sweden Priligy SE/H/0718/ Berlin-Chemie Ag Sweden Priligy SE/H/0718/001 PL 41549/0001 Farmaceutica Internazionale Srl- Uk Branch United Kingdom Priligy SE/H/0718/002 PL 41549/0002 Farmaceutica Internazionale Srl- Uk Branch United Kingdom прилижи SE/H/718/ Berlin-Chemie Ag Bulgaria прилижи SE/H/718/ Berlin-Chemie Ag Bulgaria EMA/483529/2015 Page 6/6
List of nationally authorised medicinal products
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