List of nationally authorised medicinal products

Transcription

1 12 April 2018 EMA/382206/2018 Human Medicines Evaluation Division Active substance(s): naproxen 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 provided the source is acknowledged.

2 MOMENDOL 220 mg plėvele dengtos tabletės not available LT/1/04/0014/001 AZIENDE CHIMICHE RIUNE AZIENDE CHIMICHE RIUNE MOMENDOL 220 mg plėvele dengtos tabletės not available LT/1/04/0014/002 LT Eox 220 mg filmdragerade tabletter /H/0110/ MEDA OTC AB FI AZIENDE CHIMICHE RIUNE Momendol, filmomhulde tabletten 220 mg /H/0110/001 RVG NL Momendol 220 mg - Filmtabletten /H/0110/ MOMENDOL 220 mg comprimés pelliculés /H/0110/ /02/ Momendol 220 mg film-coated tablets /H/0110/001 PA 959/2/1 Momendol 220 mg Filmtabletten /H/0110/ MOMENDOL 220 mg compresse rivestite con film /H/0110/ AZIENDE CHIMICHE RIUNE AZIENDE CHIMICHE RIUNE AZIENDE CHIMICHE RIUNE AZIENDE CHIMICHE RIUNE AZIENDE CHIMICHE RIUNE AZIENDE CHIMICHE RIUNE MOMENDOL 220 mg compresse rivestite con film /H/0110/ Momendol comprimidos revestidos por película /H/0110/ ANGELINI FARMACÊUTICA, LDA PT Momendol comprimidos revestidos por película /H/0110/ ANGELINI FARMACÊUTICA, LDA PT Momendol 220 mg επικαλυμμένα με λεπτό υμένιο δισκία /H/0110/ / ANGELINI PHARMA HELLAS S.A. GR Eox 220 mg filmdragerade tabletter /H/0110/ MEDA OTC AB SE Eox 220 mg kalvopäällysteinen tabletti /H/0110/ MEDA OTC AB FI Eox /H/0110/ MEDA OTC AB DK LT AT LU IE DE EMA/382206/2018 Page 2/9

3 Naproxen Saft InfectoPharm 250 mg/5 ml Suspension zum Einnehmen not available INFECTOPHARM ARZNEIMTEL UND CONSILIUM GMBH AT Proxen 500 mg - Filmtabletten not available GRÜNENTHAL GES. M.B.H. AT NAPSYN not available 29/0729/92-S SK NAPREBEN 550 mg capsule rigide not available MERQURIO PHARMA S.R.L. NAPREBEN 10% gel not available MERQURIO PHARMA S.R.L. MOMENDOL 10% w/w GEL /H/0110/002 PA0959/002/002 AZIENDE CHIMICHE RIUNE IE MOMENDOL 10% gel /H/0110/ AZIENDE CHIMICHE RIUNE MOMENDOL 10% gel /H/0110/ AZIENDE CHIMICHE RIUNE Momendol 100 mg/g (10%) gel /H/0110/ ANGELINI FARMACÊUTICA, LDA PT Momendol 100 mg/g (10%) gel /H/0110/ ANGELINI FARMACÊUTICA, LDA PT MOMENDOL 10% w/w GEL /H/0110/ / ANGELINI PHARMA HELLAS S.A. GR Synflex 550 mg compresse rivestite not available FARMACEUTICA Naprosyn 10% gel not available FARMACEUTICA Naprosyn 250 mg compresse gastroresistenti not available FARMACEUTICA Naprosyn 500 mg compresse gastroresistenti not available FARMACEUTICA Naprosyn 500 mg supposte not available FARMACEUTICA Naprosyn 250 mg granulato per sospensione orale not available FARMACEUTICA Naprosyn 500 mg granulato per sospensione orale not available FARMACEUTICA Naprosyn 750 mg compresse a rilascio modificato not available FARMACEUTICA Synflex 275 mg capsule rigide not available EMA/382206/2018 Page 3/9

4 FARMACEUTICA Synflex 550 mg compresse rivestite not available FARMACEUTICA Synflex 550 mg granulato per sospensione orale not available FARMACEUTICA Naproxen 500mg Tablets not available PL 44041/0026 NOUMED LIFE SCIENCES UK Laser 750 mg compresse a rilascio controllato not available EURO-PHARMA S.R.L. Naproxen Sandoz 500 mg tabletten not available BE SANDOZ N.V. BE Naproxen Sandoz 250 mg tabletten not available BE SANDOZ N.V. BE Naprosyn 250 mg tabletta not available OGYI-T- 3556/01 Dolormin GS mit Naproxen 250 mg tabletten not available JOHNSON & JOHNSON GMBH DE Dolormin für Frauen bei Menstruationsbeschwerden mit Naproxen not available JOHNSON & JOHNSON GMBH DE Dolormin für Frauen bei Menstruationsbeschwerden mit Naproxen not available JOHNSON & JOHNSON GMBH DE Dolormin für Frauen bei Menstruationsbeschwerden mit Naproxen not available JOHNSON & JOHNSON GMBH DE Dolormin GS mit Naproxen 250 mg tabletten not available JOHNSON & JOHNSON GMBH DE Dolormin GS mit Naproxen 250 mg tabletten not available JOHNSON & JOHNSON GMBH DE PREXAN 500 mg compresse not available NEW RESEARCH SRL PREXAN 500 mg granulato per sospensione orale not available NEW RESEARCH SRL PREXAN 10% Crema not available NEW RESEARCH SRL Naproxen Apotex 250 mg, zetpillen not available RVG APOTEX EUROPE B.V. NL Naproxen Apotex 500 mg, zetpillen not available RVG APOTEX EUROPE B.V. NL ALEVE 220 mg, Filmtabletten not available BE BAYER SA NV BE 220 mg compresse rivestite con film not available BAYER SPA EMA/382206/2018 Page 4/9

5 220 mg compresse rivestite con film not available BAYER SPA Aleve filmtabletta not available OGYI-T-8021/03 BAYER NGARIA KFT Aleve filmtabletta not available OGYI-T-8021/04 BAYER NGARIA KFT Aleve filmtabletta not available OGYI-T-8021/05 BAYER NGARIA KFT Aleve filmtabletta not available OGYI-T-8021/01 BAYER NGARIA KFT ALEVE 220 mg, Filmtabletten not available BAYER SA NV LU 660 mg compresse a rilascio modificato not available BAYER SPA 660 mg compresse a rilascio modificato not available BAYER SPA 660 mg compresse a rilascio modificato not available BAYER SPA ALEVETABS 220 mg, comprimé pelliculé not available BAYER HEALTHCARE ALEVETABS 220 mg, comprimé pelliculé not available BAYER HEALTHCARE ALEVETABS 220 mg, comprimé pelliculé not available BAYER HEALTHCARE ALEVE 220 mg, comprimé pelliculé not available BAYER HEALTHCARE ALEVE 220 mg, comprimé pelliculé not available BAYER HEALTHCARE ALEVE 220 mg, comprimé pelliculé not available BAYER HEALTHCARE ALEVE 220 mg, comprimé pelliculé not available BAYER HEALTHCARE Aleve Extra 660 mg retard tabletta not available OGYI-T-8021/06 BAYER NGARIA KFT Aleve Extra 660 mg retard tabletta not available OGYI-T-8021/08 BAYER NGARIA KFT Aleve Extra 660 mg retard tabletta not available OGYI-T-8021/07 BAYER NGARIA KFT Feminax Ultra 250mg Gastro-Resistant Tablets not available PL 00010/0631 BAYER PLC UK Aleve filmtabletta not available OGYI-T-8021/02 BAYER NGARIA KFT Aleve Feminax bij menstruatiepijn 275 not available RVG BAYER BV NL ALEVE not available BAYER HISPANIA SL ES Aleve Select 275 mg, omhulde tabletten not available RVG BAYER BV NL ALEVE - Filmtabletten not available BAYER AUSTRIA GMBH AT 220 mg compresse rivestite con film not available BAYER SPA 220 mg compresse rivestite con film not available BAYER SPA ALEVE 220 mg comprimés pelliculés not available BAYER SA NV LU EMA/382206/2018 Page 5/9

6 ALEVE 220 mg filmomhulde tabletten not available BE BAYER SA NV BE ALEVE 220 mg comprimés pelliculés not available BE BAYER SA NV BE Aktren Naproxen Filmtablette mit 220 mg Naproxen-Natrium not available BAYER VAL GMBH DE Aleve Filmtablette mit 220 mg Naproxen-Natrium not available BAYER VAL GMBH DE Aleve Wirkstoff: Naproxen-Natrium not available BAYER VAL GMBH DE Aleve, 220 mg, tabletki powlekane not available 7756 BAYER SP.Z.O.O PL Aleve Intense 550 mg, omhulde tablet not available RVG BAYER BV NL ALEVETABS 220 mg, comprimé pelliculé not available BAYER HEALTHCARE ALEVE 220 mg, comprimé pelliculé not available BAYER HEALTHCARE Aleve Classic bij pijn en koorts 220, omhulde tabletten not available RVG BAYER BV NL NAPROSYN 10 %, γέλη not available 65484/13/ MINERVA PHARMACEUTICAL S.A GR NAPROSYN 250 mg, γαστροανθεκτικό δισκίο not available 23554/ MINERVA PHARMACEUTICAL S.A GR NAPROSYN 500 mg, γαστροανθεκτικό δισκίο not available 21622/ MINERVA PHARMACEUTICAL S.A GR NAPROSYN 250 mg, δισκία not available 60295/13/ MINERVA PHARMACEUTICAL S.A GR NAPROSYN 500 mg, δισκία not available 45244/ MINERVA PHARMACEUTICAL S.A GR ANAPROX 550mg δισκία επικαλυμμένα not available 85120/ MINERVA PHARMACEUTICAL S.A GR NAPROSYN 250 mg, υπόθετα not available 79750/09/ MINERVA PHARMACEUTICAL S.A GR NAPROSYN 500 mg, υπόθετα not available 21344/ MINERVA PHARMACEUTICAL S.A GR Miranax 550 mg - Filmtabletten not available GRÜNENTHAL GES. M.B.H. AT Момендол 220 mg филмирани таблетки not available Apranax 275 mg filmtabletta not available OGYI-T- 3742/01 Apranax 550 mg filmtabletta not available OGYI-T- 4030/01 Apranax 275 mg filmtabletta not available OGYI-T- 3742/01 AZIENDE CHIMICHE RIUNE Apranax 550 mg filmtabletta not available OGYI-T- 4030/01 NAPRIUS 10% GEL not available AESCULAPIUS FARMACEUTICI S.R.L. EMA/382206/2018 Page 6/9 BG

7 NAPRIUS 500 mg Compresse not available AESCULAPIUS FARMACEUTICI S.R.L. NAPRIUS 500 mg Granulato per sospensione orale not available AESCULAPIUS FARMACEUTICI S.R.L. Momendol 220 mg capsule molli not available AZIENDE CHIMICHE RIUNE Momendol 220 mg capsule molli not available AZIENDE CHIMICHE RIUNE Momendol 220 mg capsule molli not available AZIENDE CHIMICHE RIUNE Momendol 220 mg capsule molli not available AZIENDE CHIMICHE RIUNE Momendol 220 mg capsule molli not available AZIENDE CHIMICHE RIUNE NAPROSSENE ANGELINI 220 mg compresse rivestite con film not available NAPROSSENE ANGELINI 220 mg compresse rivestite con film not available MOMENDOL 220 mg granulato per soluzione orale not available AZIENDE CHIMICHE RIUNE AZIENDE CHIMICHE RIUNE AZIENDE CHIMICHE RIUNE AUROBINDO PHARMA (MALTA) LIMED Naproxen Orion 250 mg tabletit NL/H/3472/ FI Naproxeno Aurobindo 250 mg comprimidos NL/H/3472/ LABORATORIOS AUROBINDO S.L.U. ES Naproxen 250mg Gastro-resistant Tablets Period Pain Reliever 250mg Gastroresistant Tablets not available PL 20075/0619 ACCORD HEALTHCARE LIMED UK Galpharm Period Pain Relief 250mg Gastro-Resistant Tablets not available PL 16028/0144 GALPHARM HEALTHCARE LIMED UK EMA/382206/2018 Page 7/9

8 Naproxen Orion 25 mg/ml oral suspension FI/H/879/01/DC PL 27925/0087 ORION CORPORATION UK NAPROSYNE 250 mg, comprimé not available NAPROSYNE 250 mg, comprimé not available NAPROSYNE 500 mg, comprimé not available NAPROSYNE 500 mg, suppositoire not available NAPROSYNE 250 mg, comprimé not available NAPROSYNE 500 mg, suppositoire not available NAPROSYNE 250 mg, comprimé not available NAPROSYNE 500 mg, comprimé not available NAPROSYNE 500 mg, comprimé not available NAPROSYNE 500 mg, comprimé not available NAPROSYNE 250 mg, comprimé not available NAPROSYNE 1000 mg, comprimé not available NAPROSYNE 500 mg, suppositoire not available NAPROSYNE 250 mg, comprimé not available NAPROSYNE 250 mg, comprimé not available NAPROSYNE 500 mg, comprimé not available NAPROSYNE 500 mg, suppositoire not available EMA/382206/2018 Page 8/9

9 NAPROSYNE 250 mg, comprimé not available Naproxen Tablets BP 500mg not available PL 21880/0111 MEDREICH PLC UK Napren-E 250 mg enterotabletter not available 6998 TAKEDA AS NO Napren-E 375 mg enterotabletter not available TAKEDA AS NO Napren-E 500 mg enterotabletter not available 6999 TAKEDA AS NO Naprostad 250 mg Filmtabletten not available STADA ARZNEIMTEL AG DE Naprostad 500 mg Filmtabletten not available STADA ARZNEIMTEL AG DE EMA/382206/2018 Page 9/9