Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 November to 15 December 2001 (Decisions taken pursuant to Article 14 of Directive 75/319/EEC or Article 22 of Directive 81/881/EEC)
Date: 2001-12-28
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product

28.12.2001

EN

Official Journal of the European Communities

C 371/11

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 November to 15 December 2001

(Decisions taken pursuant to Article 14 of Directive 75/319/EEC (1) or Article 22 of Directive 81/881/EEC (2))

(2001/C 371/07)

(cid:151) Issuing or modification of a national marketing authorisation

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the marketing authorisation

Member State concerned

Date of
notification

30.11.2001

Capthydro

See Annex

See Annex

30.11.2001

(1) OJ L 147, 9.6.1975, p. 13; as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).
(2) OJ L 317, 6.11.1981, p. 1; as last amended by Directive 93/40/EEC (OJ L 214, 24.8.1993, p. 31).

ANNEX

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES IN THE
MEMBER STATES

Member State

Marketing authorisation
holder/applicants

Trade name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

AUSTRIA

DENMARK

Tyrol Pharma
Brunnerstra(cid:223)e 59
A-1235 Wien

Tyrol Pharma
Brunnerstra(cid:223)e 59
A-1235 Wien

Multipharma BV
Gemeenschapspolderweg 28
1382 GR Weesp
The Netherlands

Multipharma BV
Gemeenschapspolderweg 28
1382 GR Weesp
The Netherlands

Co-Captotyrol

50 mg/
25 mg

Tablets

Oral use

AL/PVC

30 tablets

Co-Captotyrol

25 mg/
12,5 mg

Tablets

Oral use

AL/PVC/PVDC

30 tablets

Capthydro

50 mg/
25 mg

Tablets

Oral use

AL/PVC

30 tablets

Capthydro

25 mg/
12,5 mg

Tablets

Oral use

AL/PVC/PVDC/PP
container

30 tablets

FRANCE

Biochemie GmbH
Biochemiestra(cid:223)e 10
A-6250 Kundl

Captopril/
Hydrochloro-
thiazide
Biochemie

50 mg/
25 mg

Tablets

Oral use

AL/PVC

28 tablets

Biochemie GmbH
Biochemiestra(cid:223)e 10
A-6250 Kundl

Captopril/
Hydrochloro-
thiazide

25 mg/
12,5 mg

Tablets

Oral use

AL/PVC/PVDC

28 tablets

C 371/12

EN

Official Journal of the European Communities

28.12.2001

Member State

Marketing authorisation
holder/applicants

Trade name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

GREECE

Novartis (Hellas) SACI
12th Kilometer National
Road No 1
GR-144 54 Metamorphosis
Athen

Novartis (Hellas) SACI
12th Kilometer National
Road No 1
GR-144 54 Metamorphosis
Athen

PORTUGAL

Laborat(cid:243)rio Normal
Rua do Centro Empresarial
Edif(cid:237)cio 8 Quinta da Beloura
P-2710-444 Sintra

Laborat(cid:243)rio Normal
Rua do Centro Empresarial
Edif(cid:237)cio 8 Quinta da Beloura
P-2710-444 Sintra

SPAIN

Laboratorios GØminis SA
Gran Via de les Corts
Catalanes, 764
E-08013 Barcelona

Laboratorios GØminis SA
Gran Via de les Corts
Catalanes, 764
E-08013 Barcelona

SancazidTM

50 mg/
25 mg

Tablets

Oral use

AL/PVC

20 tablets

SancazidTM

25 mg/
12,5 mg

Tablets

Oral use

AL/PVC/PVDC

20 tablets

50 mg/
25 mg

25 mg/
12,5 mg

50 mg/
25 mg

Tablets

Oral use

AL/PVC

Tablets

Oral use

AL/PVC/PVDC

20, 30, 60
tablets

20, 30, 60
tablets

Tablets

Oral use

AL/PVC

30 tablets

25 mg/
12,5 mg

Tablets

Oral use

AL/PVC/PVDC/PP
container

500 tablets

Captopril/
Hidrocloro-
tiazida
comprimidos
50/25 mg

Captopril/
Hidrocloro-
tiazida
comprimidos
50/25 mg

Captopril/
Hidrocloro-
tiazida Multi-
pharma
50 mg/25 mg
comprimidos
EFG

Captopril/
Hidrocloro-
tiazida Multi-
pharma
50 mg/25 mg
comprimidos
EFG

THE
NETHERLANDS

Multipharma BV
Gemeenschapspolderweg 28
1382 GR Weesp
The Netherlands

MP-Captopril/
Hydrochloro-
thiazide

50 mg/
25 mg

Tablets

Oral use

AL/PVC

30 tablets

Multipharma BV
Gemeenschapspolderweg 28
1382 GR Weesp
The Netherlands

MP-Captopril/
Hydrochloro-
thiazide

25 mg/
12,5 mg

Tablets

Oral use

AL/PVC/PVDC

30 tablets

UNITED
KINGDOM

Multipharma BV
Gemeenschapspolderweg 28
1382 GR Weesp
The Netherlands

Captopril/
Hydrochloro-
thiazide

50 mg/
25 mg

Tablets

Oral use

AL/PVC

30 tablets

Multipharma BV
Gemeenschapspolderweg 28
1382 GR Weesp
The Netherlands

Captopril/
Hydrochloro-
thiazide

25 mg/
12,5 mg

Tablets

Oral use

AL/PVC/PVDC

30 tablets