Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 January to 15 February 2001 (Decisions taken pursuant to Article 14 of Directive 75/319/EEC or Article 22 of Directive 81/851/EEC)
Date: 2001-02-20
Institutions: European Commission
Subjects: EU Member State, marketing, marketing standard, medicinal product

20.2.2001

EN

Official Journal of the European Communities

C 53/5

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

29.1.2001

Pirsue

Pharmacia & Upjohn
Rijkweg 12
B-2870 Puurs

EU/2/00/027/001-003

31.1.2001

(cid:151) Modification of a marketing authorisation (Article 34 of Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

2.2.2001

Stronghold

6.2.2001

Econor

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Novartis Animal
Health Austria GmbH
Biochemiestra(cid:223)e 10
A-6250 Kundl

EU/2/99/014/001-011

6.2.2001

EU/2/98/010/023-024

7.2.2001

Anyone wishing to consult the public assessment report on the medicinal products in question and the
decisions relating thereto is invited to contact:

The European Agency for the Evaluation of Medicinal Products
7, Westferry Circus, Canary Wharf
London E14 4HB
United Kingdom

Summary of Community decisions on marketing authorisations in respect of medicinal products

from 15 January to 15 February 2001

(Decisions taken pursuant to Article 14 of Directive 75/319/EEC (1) or Article 22 of Directive 81/851/EEC (2))

(2001/C 53/03)

(cid:151) 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

6.2.2001

Glucophage

See Annex

See Annex

6.6.2001

(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).

C 53/6

EN

Official Journal of the European Communities

20.2.2001

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

Trade name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

AUSTRIA

Merck GmbH Austria
Zimbagasse 5
A-1147 Wien

Merck GmbH Austria
Zimbagasse 5
A-1147 Wien

Merck GmbH Austria
Zimbagasse 5
A-1147 Wien

Merck GmbH Austria
Zimbagasse 5
A-1147 Wien

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

BELGIUM

Merck Belgolabo NV
Brusselsesteenweg 288
B-3090 Overijse

Glucophage

500 mg

Film-coated tablet Oral use

Merck Belgolabo NV
Brusselsesteenweg 288
B-3090 Overijse

Merck Belgolabo NV
Brusselsesteenweg 288
B-3090 Overijse

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

500 mg

Film-coated tablet Oral use

DENMARK

FINLAND

FRANCE

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

40

200

30

100

60

60

100

100

100

50

100

30

50

20.2.2001

EN

Official Journal of the European Communities

C 53/7

Member State

Marketing authorisation holder

Trade name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

FRANCE
(cont(cid:146)d)

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

500 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

1 000

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

GERMANY

Merck KGaA
Frankfurter Stra(cid:223)e 250
D-67293 Darmstadt

Glucophage

500 mg

Film-coated tablet Oral use

Merck KGaA
Frankfurter Stra(cid:223)e 250
D-67293 Darmstadt

Merck KGaA
Frankfurter Stra(cid:223)e 250
D-67293 Darmstadt

Merck KGaA
Frankfurter Stra(cid:223)e 250
D-67293 Darmstadt

Merck KGaA
Frankfurter Stra(cid:223)e 250
D-67293 Darmstadt

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

100

500

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Bottle
(polypropylene)

Blister
(PVC/aluminium)

10

30

50

60

100

300

30

120

600

600

30

C 53/8

EN

Official Journal of the European Communities

20.2.2001

Member State

Marketing authorisation holder

Trade name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

GERMANY
(cont(cid:146)d)

Merck KGaA
Frankfurter Stra(cid:223)e 250
D-67293 Darmstadt

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Bottle
(polypropylene)

Bottle
(polypropylene)

Glucophage

500 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Glucophage

500 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Glucophage

500 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

120

600

600

30

9

21

84

Glucophage

500 mg

Film-coated tablet Oral use

Bottle
(polypropylene)

100

Glucophage

500 mg

Film-coated tablet Oral use

Bottle
(polypropylene)

500

Glucophage

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

8

GREECE

IRELAND

Merck KGaA
Frankfurter Stra(cid:223)e 250
D-67293 Darmstadt

Merck KGaA
Frankfurter Stra(cid:223)e 250
D-67293 Darmstadt

N. Petsiavas SA
11 Nicodimou St. & Voulis
GR-10558 Athens

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG
United Kingdom

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG
United Kingdom

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG
United Kingdom

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG
United Kingdom

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG
United Kingdom

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG
United Kingdom

20.2.2001

EN

Official Journal of the European Communities

C 53/9

Member State

Marketing authorisation holder

Trade name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

IRELAND
(cont(cid:146)d)

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG
United Kingdom

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG
United Kingdom

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG
United Kingdom

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG
United Kingdom

Glucophage

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Glucophage

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Glucophage

850 mg

Film-coated tablet Oral use

Bottle
(polypropylene)

14

56

60

Glucophage

850 mg

Film-coated tablet Oral use

Bottle
(polypropylene)

300

ITALY

Lipha SpA
Via Garibaldi 80/82
I-50041 Calenzano (FI)

Glucophage

500 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Lipha SpA
Via Garibaldi 80/82
I-50041 Calenzano (FI)

Glucophage
Forte

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

LUXEMBOURG

Merck Belgolabo NV
Brusselsesteenweg 288
B-3090 Overijse

Glucophage

500 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

30

40

60

Merck Belgolabo NV
Brusselsesteenweg 288
B-3090 Overijse

Glucophage

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

100

PORTUGAL

Laquifa SA
Rua Alfredo da Silva, 3 C
P-1300 Lisboa

Glucophage

500 mg

Film-coated tablet Oral use

Laquifa SA
Rua Alfredo da Silva, 3 C
P-1300 Lisboa

Laquifa SA
Rua Alfredo da Silva, 3 C
P-1300 Lisboa

Laquifa SA
Rua Alfredo da Silva, 3 C
P-1300 Lisboa

Glucophage

500 mg

Film-coated tablet Oral use

Risidon

850 mg

Film-coated tablet Oral use

Risidon

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

20

50

20

60

C 53/10

EN

Official Journal of the European Communities

20.2.2001

Member State

Marketing authorisation holder

Trade name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

SPAIN

SWEDEN

Roche SA
Josefa ValcÆrcel, 42
E-28027 Madrid

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Lipha SantØ
37, rue Saint-Romain
F-69008 Lyon

Dianben

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

50

Glucophage

500 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

1 ((cid:215)100)

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

500 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Bottle
(polypropylene)

100

400

Glucophage

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

1 ((cid:215)100)

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Bottle
(polypropylene)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

Blister
(PVC/aluminium)

100

200

50

90

100

90

100

9

THE
NETHERLANDS

Merck Nederland BV
Postbus 8198
1005 AD Amsterdam

Glucophage

500 mg

Film-coated tablet Oral use

Merck Nederland BV
Postbus 8198
1005 AD Amsterdam

Merck Nederland BV
Postbus 8198
1005 AD Amsterdam

Merck Nederland BV
Postbus 8198
1005 AD Amsterdam

Merck Nederland BV
Postbus 8198
1005 AD Amsterdam

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

Glucophage

850 mg

Film-coated tablet Oral use

UNITED
KINGDOM

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG

Glucophage

500 mg

Film-coated tablet Oral use

20.2.2001

EN

Official Journal of the European Communities

C 53/11

Member State

Marketing authorisation holder

Trade name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

UNITED
KINGDOM
(cont(cid:146)d)

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG

Lipha Pharmaceuticals Ltd
Harrier House
High Street, Yiewsley
West Drayton
Middlesex UB7 7QG

Glucophage

500 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Glucophage

500 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Glucophage

500 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Glucophage

500 mg

Film-coated tablet Oral use

Glucophage

500 mg

Film-coated tablet Oral use

Bottle
(polypropylene)

Bottle
(polypropylene)

Glucophage

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Glucophage

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Glucophage

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Glucophage

850 mg

Film-coated tablet Oral use

Blister
(PVC/aluminium)

Glucophage

850 mg

Film-coated tablet Oral use

Bottle
(polypropylene)

21

56

84

100

500

9

21

56

84

60

Glucophage

850 mg

Film-coated tablet Oral use

Bottle
(polypropylene)

300