14 December 2016 EMA/45259/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance(s): captopril / hydrochlorothiazide Procedure No.: PSUSA/00000536/201604

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 full name (in authorisation country) ACEDIUR 50 mg + 15 mg compresse

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

not available

025767029

IT

ACEDIUR 50mg + 25mg compresse

not available

025767017

Aceplus 50 mg + 25 mg compresse Capozide (Captopril 50mg / Hydrochlorothiazide 25mg) tablets Capozide (Captopril 50mg / Hydrochlorothiazide 25mg) tablets Capozide forte - Tabletten

AT/H/0673/001

026067013

AT/H/0673/001

PA 0002/053/002

A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE S.R.L. A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE S.R.L. BRISTOL-MYERS SQUIBB S.R.L. BRISTOL-MYERS SQUIBB PHARMACEUTICALS LIMITED

AT/H/0673/001

PL 00034/0263

E.R. SQUIBB & SONS LIMITED

UK

AT/H/0673/001

1-18153

AT

CAPTEA COMPRIME SECABLE CAPTEA COMPRIME SECABLE CAPTEA COMPRIME SECABLE CAPTEA COMPRIME SECABLE CaptoHEXAL® comp 25 mg/12,5 mg Captopril/HCT AL 25/12,5 Captopril-HCT STADA® 25 mg/12,5 mg Tabletten Ecadiu 50/25 mg comprimidos Ecazide 50 mg/25 mg comprimidos ECAZIDE® comprimé sécable ECAZIDE® comprimé sécable

not available

398 905.2

BRISTOL-MYERS SQUIBB GESMBH SANOFI-AVENTIS FRANCE

not available

372 227-7

SANOFI-AVENTIS FRANCE

FR

not available

398 354.6

SANOFI-AVENTIS FRANCE

FR

not available

329 129-7

SANOFI-AVENTIS FRANCE

FR

2131471

31471.00.00

HEXAL AG

DE

not available not available

41218.00.00 30103.02.00

ALIUD PHARMA GMBH STADAPHARM GMBH

DE DE

NOT APPLICABLE

58.770

ES

AT/H/0673/001

58.511

SANDOZ FARMACÉUTICA, S.A. BRISTOL-MYERS SQUIBB SA

AT/H/0673/001

3400936038165

BRISTOL-MYERS SQUIBB

FR

AT/H/0673/001

3400939748955

BRISTOL-MYERS SQUIBB

FR

List of nationally authorised medicinal products EMA/45259/2017

IT IT IE

FR

ES

Page 2/3

Product full name (in authorisation country) Lopiretic, 50 mg + 25 mg, comprimidos

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

AT/H/0673/001

4655783

PT

Lopiretic, 50 mg + 25 mg, comprimidos

AT/H/0673/001

8681700

Lopiretic, 50 mg + 25 mg, comprimidos

AT/H/0673/001

8681726

Lopiretic, 50 mg + 25 mg, comprimidos

AT/H/0673/001

8681718

Superace (50+25) mg δισκία URESAN® Tab (50+25)mg

DE/H/0769/002

35288/14-05-2013

not available

669

BRISTOL-MYERS SQUIBB FARMACÊUTICA PORTUGUESA, SA BRISTOL-MYERS SQUIBB FARMACÊUTICA PORTUGUESA, SA BRISTOL-MYERS SQUIBB FARMACÊUTICA PORTUGUESA, SA BRISTOL-MYERS SQUIBB FARMACÊUTICA PORTUGUESA, SA PHARMASWISS ČESKÁ REPUBLIKA S.R.O. A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE S.R.L.

List of nationally authorised medicinal products EMA/45259/2017

PT PT PT GR GR

Page 3/3

PSUSA/00000536/201604 - European Medicines Agency - Europa EU

Dec 14, 2016 - Send a question via our website www.ema.europa.eu/contact. © European ... Page 2/3. Product full name ... not available. 025767029.

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