12 January 2017 EMA/36356/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine

Procedure no.: PSUSA/00001696/201605

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

ATARAX® (Hydroxyzine

not available

MA030/00102

UCB PHARMA S.A. (ANDERL

MT

dihydrochloride) ATARAX syrup ®

BE) not available

MA030/00101

(Hydroxyzine

UCB PHARMA S.A. (ANDERL

MT

BE)

dihydrochloride) Atarax, tabletki

not available

R/2940

powlekane, 10 mg Atarax, tabletki

PL

BE) not available

R/2941

powlekane, 25 mg Atarax, 2 mg/ml, syrop

UCB PHARMA S.A. (ANDERL

UCB PHARMA S.A. (ANDERL

PL

BE) not available

R/2939

UCB PHARMA S.A. (ANDERL

PL

BE) Atarax 25 mg

not available

16161

Filmtabletten Atarax 25 mg

UCB PHARMA GMBH (VIENNA

AT

AT) not available

5798

kalvopäällysteinen

UCB PHARMA OY FINLAND

FI

(ESPOO FI)

tabletti Atarax 2 mg/ml siirappi

not available

5794

UCB PHARMA OY FINLAND

FI

(ESPOO FI) Atarax 25 mg filmtabletta

not available

OGYI-T-4577/01

UCB MAGYARORSZÁG KFT

HU

(BUDAPEST HU) Atarax 100 mg,

not available

filmomhulde tabletten

List of nationally authorised medicinal products EMA/36356/2017

BE045105

UCB PHARMA S.A. (ANDERL

BE

BE)

Page 2/7

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Atarax 10 mg,

not available

BE045087

UCB PHARMA S.A. (ANDERL

BE

filmomhulde tabletten Atarax 25 mg,

BE) not available

BE045096

filmomhulde tabletten Atarax 10 mg, com

not available

BE045087

not available

BE045096

not available

BE045105

not available

20030268

not available

940066

UCB PHARMA S.A. (ANDERL

BE

UCB PHARMA S.A. (ANDERL

BG

UCB NORDIC A/S

IS

(COPENHAGEN DK) not available

940129

lausn ATARAX 20 mg/10 ml

BE

BE)

filmuhúðaðar töflur Atarax 2 mg/ml mixtúra,

UCB PHARMA S.A. (ANDERL

BE)

филмирани таблетки Atarax 25 mg

BE

BE)

primes pellicules АТАРАКС 25 mg

UCB PHARMA S.A. (ANDERL BE)

pellicules Atarax 1 00 mg, com

BE

BE)

primes pellicules Atarax 25 mg, comprimes

UCB PHARMA S.A. (ANDERL

UCB NORDIC A/S

IS

(COPENHAGEN DK) not available

010834012

UCB PHARMA SPA (MILAN IT)

IT

sciroppo

List of nationally authorised medicinal products EMA/382258/2015

Page 3/7

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

ATARAX 25 mg

not available

010834024

UCB PHARMA SPA (MILAN IT)

IT

not available

34009 300 814 3 3

UCB PHARMA S.A.

FR

compresse rivestite con film ATARAX, sirop

(COLOMBES FR) ATARAX 25 mg,

not available

34009 300 813 7 2

comprimé pelliculé

UCB PHARMA S.A.

FR

(COLOMBES FR)

sécable Atarax 10 mg, com

not available

0072/10010668

primes pellicules Atarax 100 mg, com

not available

0072/10010666

UCB PHARMA S.A. (ANDERL

LU

BE) not available

0072/10010669

pellicules AH 3® N Tabletten

LU

BE)

primes pellicules Atarax 25 mg, comprimes

UCB PHARMA S.A. (ANDERL

UCB PHARMA S.A. (ANDERL

LU

BE) not available

15189.00.00

UCB PHARMA GMBH

DE

(MONHEIM DE) Atarax Tabletten

not available

7081.00.00

UCB PHARMA GMBH

DE

(MONHEIM DE) ATARAX 10 mg tabletter,

not available

filmdrasjerte

List of nationally authorised medicinal products EMA/382258/2015

3491

UCB NORDIC A/S

NO

(COPENHAGEN DK)

Page 4/7

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

ATARAX 25 mg tabletter,

not available

3492

UCB NORDIC A/S

NO

filmdrasjerte Atarax

(COPENHAGEN DK) not available

70/0891/92-C/S

UCB PHARMA S.R.O.

SK

(PRAGUE CZ) Atarax 10 mg

not available

5325

filmdragerade tabletter Atarax 25 mg

SE

(COPENHAGEN DK) not available

5326

filmdragerade tabletter Atarax 2 mg/ml oral

UCB NORDIC A/S

UCB NORDIC A/S

SE

(COPENHAGEN DK) not available

5327

lösning

UCB NORDIC A/S

SE

(COPENHAGEN DK)

EFIDAC

not available

41921/24-9-2008

OLVOS SCIENCE S.A.

GR

ATARAX 25mg

not available

70/891/92-C

UCB PHARMA S.A. (ANDERL

CZ

potahované tablety Hydroxyzine-2HCL 25,

BE) not available

RVG 50110

omhulde tabletten 25 mg Hydroxyzine-2HCL 10,

UCB PHARMA B.V. (BREDA

NL

NL) not available

omhulde tabletten 10 mg

List of nationally authorised medicinal products EMA/382258/2015

RVG 50109

UCB PHARMA B.V. (BREDA

NL

NL)

Page 5/7

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Atarax 25 mg

not available

5475397

UCB PHARMA (PRODUTOS

PT

comprimidos revestidos

FARMACÊUTICOS), LDA.

por película

(PACO PT)

Atarax 25 mg

not available

9641621

UCB PHARMA (PRODUTOS

comprimidos revestidos

FARMACÊUTICOS), LDA.

por película

(PACO PT)

Atarax 2 mg/ml xarope

not available

9934604

UCB PHARMA (PRODUTOS

PT

PT

FARMACÊUTICOS), LDA. (PACO PT) Atarax 25 mg

not available

926.308

comprimidos recubiertos

UCB PHARMA S.A. (MADRID

ES

ES)

con película Atarax 2 mg/ml jarabe

not available

926.269

UCB PHARMA S.A. (MADRID

ES

ES) ATARAX®

not available

47915/14-10-2008

UCB A.E. (ATHENS GR)

GR

ATARAX®

not available

4791714-10-2008

UCB A.E. (ATHENS GR)

GR

ATARAX®

not available

47909/14-10-2008

UCB A.E. (ATHENS GR)

GR

ATARAX (Hydroxyzine

not available

313

UCB PHARMA S.A. (ANDERL

CY

dihydrochloride) 25 mg

BE)

film-coated tablet

List of nationally authorised medicinal products EMA/382258/2015

Page 6/7

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

ATARAX (Hydroxyzine

not available

315

UCB PHARMA S.A. (ANDERL

CY

dihydrochloride) 2 mg/ml

BE)

syrup

List of nationally authorised medicinal products EMA/382258/2015

Page 7/7

hydroxyzine chloride / hydroxyzine pamoate and all fixed combination ...

Jan 12, 2017 - Send a question via our website www.ema.europa.eu/contact ... Page 2/7. Product Name (in ... Atarax 25 mg filmtabletta not available.
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