List of nationally authorised medicinal products

Transcription

1 12 July 2018 EMA/462856/2018 Human Medicines Evaluation Division Active substance: econazole, econazole nitrate / triamcinolone acetonide, econazole nitrate / zinc oxide 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 ECONAZOLE TEVA SANTE 1 POUR CENT, solution pour application cutanée ECONAZOLE BIOGARAN 1%, crème Epi-Pevaryl 1 % Crème Epi-Pevaryl 1 % Lotio Epi-Pevaryl 1 % Crème Epi-Pevaryl 1 % Crème Epi-Pevaryl 1 % Crème not available NL20507 TEVA SANTÉ not available BIOGARAN not available JOHNSON & JOHNSON GMBH DE not available JOHNSON & JOHNSON GMBH DE not available JOHNSON & JOHNSON GMBH DE not available JOHNSON & JOHNSON GMBH DE not available JOHNSON & JOHNSON GMBH DE EMA/462856/2018 Page 2/8

3 Pevaryl 150 mg vagitorier not available MCNEIL SWEDEN AB SE Pevaryl 1% puder not available 9267 MCNEIL SWEDEN AB SE Pevaryl Depot 150 mg not available MCNEIL SWEDEN AB SE vagitorier Epi-Pevaryl P.v. 1 % not available JOHNSON & JOHNSON GMBH DE Lösung Gyno-Pevaryl 10 mg/g not available JOHNSON & JOHNSON LDA PT creme vaginal Epi-Pevaryl P.v. 1 % not available JOHNSON & JOHNSON GMBH DE Lösung PEVARYL 1 POUR CENT, not available JOHNSON & JOHNSON solution pour application locale en flacon pulvérisateur SANTÉ BEAUTÉ ANCE PEVARYL 1 POUR CENT, not available JOHNSON & JOHNSON crème SANTÉ BEAUTÉ ANCE PEVARYL 1 POUR CENT, not available JOHNSON & JOHNSON émulsion fluide pour application locale SANTÉ BEAUTÉ ANCE Pevaryl 1% kräm not available 9266 MCNEIL SWEDEN AB SE Pevaryl 1% kräm not available 9266 MCNEIL SWEDEN AB SE PEVARYL 1 POUR CENT, poudre pour application locale en flacon poudreur not available JOHNSON & JOHNSON SANTÉ BEAUTÉ ANCE EMA/462856/2018 Page 3/8

4 Gyno-Pevaryl Combipack (10 mg/g) + (150 mg) Creme vaginal + Óvulo not available JOHNSON & JOHNSON, LDA. PT Pevaryl 10 mg/g creme not available JOHNSON & JOHNSON LDA PT Pevaryl 150 mg vagitorier och Pevaryl 1% kräm not available MCNEIL SWEDEN AB SE Pevaryl Depot 150 mg not available MCNEIL SWEDEN AB SE vagitorier och Pevaryl 1% kräm Pevaryl 10 mg/g pó para not available JOHNSON & JOHNSON LDA PT pulverização cutânea Pevaryl 10 mg/g solução not available JOHNSON & JOHNSON LDA PT para pulverização cutânea Pevaryl 10 mg/g solução not available JOHNSON & JOHNSON LDA PT para pulverização cutânea Gyno-Pevaryl 150 mg not available JOHNSON & JOHNSON LDA PT óvulos Pevaryl 1 % krem not available 6230 TRIMB HEALTHCARE AB NO Pevaryl 1 % pudder not available 7653 TRIMB HEALTHCARE AB NO Pevaryl 150 mg vagitorier not available 6457 TRIMB HEALTHCARE AB NO Pevaryl Depot 150 mg vagitorie Pevaryl 1 % krem og Pevaryl 150 mg vagitorier not available 7282 TRIMB HEALTHCARE AB NO not available 6751 TRIMB HEALTHCARE AB NO EMA/462856/2018 Page 4/8

5 Pevaryl Depot not available TRIMB HEALTHCARE AB NO Kombinasjonspakning, vagitorie 150 mg og krem 1 % Pevaryl 10mg/g Creme not available TRIMB HEALTHCARE AB AT Pevaryl 1% krem not available TRIMB HEALTHCARE AB IS GYNO-PEVARYL 50, vaginální cípky GYNO-PEVARYL 150, vaginální čípky + GYNO- PEVARYL 50, krém GYNO-PEVARYL 150, vaginální cípky Pevaryl Lady 150 mg hüvelykúp Pevaryl Depot 150 mg skeiðarstílar Pevaryl 150 mg skeiðarstílar og Pevaryl 1% krem Pevaryl Depot 150 mg skeiðarstílar og Pevaryl 1% krem Ecorex 1% crema vaginale Ecorex 0,1% lavande vaginali not available 54/151/77-A/C TRIMB HEALTHCARE AB CZ not available 54/637/92-C TRIMB HEALTHCARE AB CZ not available 54/151/77-B/C TRIMB HEALTHCARE AB CZ not available OGYI-T-7337/01 TRIMB HEALTHCARE AB HU not available TRIMB HEALTHCARE AB IS not available TRIMB HEALTHCARE AB IS not available TRIMB HEALTHCARE AB IS not available TEOFARMA S.R.L. IT not available TEOFARMA S.R.L. IT EMA/462856/2018 Page 5/8

6 Ecorex 150 mg ovuli not available TEOFARMA S.R.L. IT Ecorex 1% crema not available TEOFARMA S.R.L. IT Ecorex 1% emulsione not available TEOFARMA S.R.L. IT ECONAZOLE BIOGARAN not available BIOGARAN 1%, émulsion pour application cutanée IFENEC 1% soluzione not available ITALFARMACO S.P.A IT IFENEC 1% soluzione not available ITALFARMACO S.P.A IT IFENEC 150 mg ovuli not available ITALFARMACO S.P.A IT IFENEC 150 mg ovuli not available ITALFARMACO S.P.A IT IFENEC 1% polvere not available ITALFARMACO S.P.A IT IFENEC 1% polvere not available ITALFARMACO S.P.A IT IFENEC 1% soluzione not available ITALFARMACO S.P.A IT per genitali esterni IFENEC 1% crema not available ITALFARMACO S.P.A IT IFENEC 1% emulsione not available ITALFARMACO S.P.A IT IFENEC 50 mg ovuli not available ITALFARMACO S.P.A IT EMA/462856/2018 Page 6/8

7 IFENEC 50 mg ovuli not available ITALFARMACO S.P.A IT IFENEC 50 mg ovuli not available ITALFARMACO S.P.A IT IFENEC 1% crema not available ITALFARMACO S.P.A IT vaginale IFENEC 1% crema not available ITALFARMACO S.P.A IT vaginale ECODERGIN 1% CREMA not available FARMITALIA S.R.L. IT VAGINALE ECODERGIN 150 MG not available FARMITALIA S.R.L. IT OVULI ECODERGIN 150 MG not available FARMITALIA S.R.L. IT OVULI ECODERGIN 1% CREMA not available FARMITALIA S.R.L. IT ECONAZOLE RPG 1 POUR CENT, émulsion fluide pour application cutanée ECONAZOLE RPG 1 POUR CENT, poudre pour application cutanée ECONAZOLE RPG 1 POUR CENT, crème ECONAZOLE TEVA SANTE 1 POUR CENT, poudre pour application cutanée not available NL RANBAXY PHARMACIE GENERIQUES not available NL RANBAXY PHARMACIE GENERIQUES not available NL RANBAXY PHARMACIE GENERIQUES not available NL20509 TEVA SANTÉ EMA/462856/2018 Page 7/8

8 ECONAZOLE TEVA SANTÉ 1 POUR CENT, émulsion fluide pour application cutanée MYCOAPAISYL 1 POUR CENT, crème MYCOAPAISYL 1 POUR CENT, émulsion fluide pour application cutanée MYCOAPAISYL 1 POUR CENT, poudre pour application cutanée ECONAZOLE BIOGARAN 1%, solution pour application cutanée en flacon pressurisé ECONAZOLE RATIOPHARM 1 POUR CENT, crème ECONAZOLE BIOGARAN 1%, poudre pour application cutanée not available NL20508 TEVA SANTÉ not available MERCK MÉDICATION FAMILIALE S.A.S. not available MERCK MÉDICATION FAMILIALE S.A.S. not available MERCK MÉDICATION FAMILIALE S.A.S. not available BIOGARAN not available NL20510 TEVA SANTÉ not available BIOGARAN EMA/462856/2018 Page 8/8