List of nationally authorised medicinal products

Transcription

1 12 January 2017 EMA/36356/2017 Human Medicines Evaluation Division Active substance: hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine 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 ATARAX (Hydroxyzine dihydrochloride) not available MA030/00102 UCB PHARMA S.A. (ANDERL MT ATARAX syrup (Hydroxyzine dihydrochloride) Atarax, tabletki powlekane, 10 mg not available MA030/00101 UCB PHARMA S.A. (ANDERL not available R/2940 UCB PHARMA S.A. (ANDERL MT PL Atarax, tabletki powlekane, 25 mg not available R/2941 UCB PHARMA S.A. (ANDERL PL Atarax, 2 mg/ml, syrop not available R/2939 UCB PHARMA S.A. (ANDERL PL Filmtabletten not available UCB PHARMA GMBH (VIENNA AT) AT kalvopäällysteinen tabletti not available 5798 UCB PHARMA OY FINLAND (ESPOO FI) Atarax 2 mg/ml siirappi not available 5794 UCB PHARMA OY FINLAND (ESPOO FI) FI FI filmtabletta not available OGYI-T-4577/01 UCB MAGYARORSZÁG KFT (BUDAPEST HU) HU Atarax 100 mg, filmomhulde tabletten not available UCB PHARMA S.A. (ANDERL EMA/36356/2017 Page 2/7

3 Atarax 10 mg, filmomhulde tabletten not available UCB PHARMA S.A. (ANDERL, filmomhulde tabletten not available UCB PHARMA S.A. (ANDERL Atarax 10 mg, com not available UCB PHARMA S.A. (ANDERL, comprimes pellicules not available UCB PHARMA S.A. (ANDERL Atarax 1 00 mg, com not available UCB PHARMA S.A. (ANDERL АТАРАКС 25 mg филмирани таблетки not available UCB PHARMA S.A. (ANDERL BG filmuhúðaðar töflur not available UCB NORDIC A/S IS Atarax 2 mg/ml mixtúra, lausn not available UCB NORDIC A/S IS ATARAX 20 mg/10 ml sciroppo not available UCB PHARMA SPA (MILAN IT) IT EMA/382258/2015 Page 3/7

4 ATARAX 25 mg not available UCB PHARMA SPA (MILAN IT) IT compresse rivestite con film ATARAX, sirop not available UCB PHARMA S.A. (COLOMS FR) FR ATARAX 25 mg, comprimé pelliculé sécable Atarax 10 mg, com not available UCB PHARMA S.A. (COLOMS FR) not available 0072/ UCB PHARMA S.A. (ANDERL FR LU Atarax 100 mg, com not available 0072/ UCB PHARMA S.A. (ANDERL LU, comprimes pellicules not available 0072/ UCB PHARMA S.A. (ANDERL LU AH 3 N Tabletten not available UCB PHARMA GMBH (MONHEIM DE) DE Atarax Tabletten not available UCB PHARMA GMBH (MONHEIM DE) DE ATARAX 10 mg tabletter, filmdrasjerte not available 3491 UCB NORDIC A/S NO EMA/382258/2015 Page 4/7

5 ATARAX 25 mg tabletter, filmdrasjerte not available 3492 UCB NORDIC A/S NO Atarax not available 70/0891/92-C/S UCB PHARMA S.R.O. (PRAGUE CZ) SK Atarax 10 mg filmdragerade tabletter not available 5325 UCB NORDIC A/S SE filmdragerade tabletter not available 5326 UCB NORDIC A/S SE Atarax 2 mg/ml oral lösning not available 5327 UCB NORDIC A/S SE EFIDAC not available 41921/ OLVOS SCIENCE S.A. GR ATARAX 25mg potahované tablety not available 70/891/92-C UCB PHARMA S.A. (ANDERL CZ Hydroxyzine-2HCL 25, omhulde tabletten 25 mg not available RVG UCB PHARMA B.V. (BREDA NL) NL Hydroxyzine-2HCL 10, omhulde tabletten 10 mg not available RVG UCB PHARMA B.V. (BREDA NL) NL EMA/382258/2015 Page 5/7

6 comprimidos revestidos por película not available UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT) not available UCB PHARMA (PRODUTOS comprimidos revestidos FARMACÊUTICOS), LDA. por película (PACO PT) Atarax 2 mg/ml xarope not available UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT) not available UCB PHARMA S.A. (MADRID comprimidos recubiertos ES) con película Atarax 2 mg/ml jarabe not available UCB PHARMA S.A. (MADRID ES) PT PT PT ES ES ATARAX not available 47915/ UCB A.E. (ATHENS GR) GR ATARAX not available UCB A.E. (ATHENS GR) GR ATARAX not available 47909/ UCB A.E. (ATHENS GR) GR ATARAX (Hydroxyzine dihydrochloride) 25 mg film-coated tablet not available 313 UCB PHARMA S.A. (ANDERL CY EMA/382258/2015 Page 6/7

7 ATARAX (Hydroxyzine dihydrochloride) 2 mg/ml syrup not available 315 UCB PHARMA S.A. (ANDERL CY EMA/382258/2015 Page 7/7