Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 February 2004 to 15 March 2004 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2004-03-26
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product

26.3.2004

EN

Official Journal of the European Union

C 77/7

— Withdrawal of a marketing authorisation (Article 34 of Regulation (EEC) No 2309/93)

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

2.3.2004

Pulsaflox

Virbac SA
1e Avenue 2065
m L.I.D.
F-06516 Carros

EU/2/00/023/001-003

4.3.2004

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 authorizations in respect of medicinal products
from 15 February 2004 to 15 March 2004

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

— Issuing, maintenance or modification of a national marketing authorisation

(2004/C 77/03)

Date of the
decision

Name of the medicinal product

Holder of the marketing
authorization

Member State concerned

Date of
notification

20.2.2004

Gatifloxacin

See Annex I

See Annex I

23.2.2004

1.12.2003

Calcichew-D3 mite

See Annex II

See Annex II

5.12.2003

23.2.2004

Cardiostad

See Annex III

See Annex III

26.2.2004

23.2.2004

Lisinopril Biochemie

See Annex IV

See Annex IV

26.2.2004

2.3.2004

Pravachol

See Annex V

See Annex V

3.3.2004

(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES
OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS, PACKAGING AND
PACKAGE SIZES IN THE MEMBER STATES AND NORWAY AND ICELAND

ANNEX I

Member State

Marketing Authorisation
holder

Applicant

Invented Name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package size

Austria

Finland

Germany

Iceland

Italy

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Bonoq 400 mg
Filmtabletten

Crispin 400 mg
Filmtabletten

400 mg

Film-coated tablets Oral

400 mg

Film-coated tablets Oral

Bonoq

400 mg

Film-coated tablets Oral

Crispin

400 mg

Film-coated tablets Oral

Crispin 400 mg
Filmtabletten

Bonoq 400 mg
Filmtabletten

400 mg

Film-coated tablets Oral

400 mg

Film-coated tablets Oral

Bonoq

400 mg

Film-coated tablets Oral

Crispin

400 mg

Film-coated tablets Oral

Bonoq 400 mg

400 mg

Film-coated tablets Oral

Crispin 400 mg

400 mg

Film-coated tablets Oral

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Blister

Blister

Blister

Blister

Blister

Blister

Blister

Blister

Blister

Blister

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

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Member State

Marketing Authorisation
holder

Applicant

Invented Name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package size

Luxembourg

Netherland

Portugal

Spain

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Bonoq 400 mg

400 mg

Film-coated tablets Oral

Crispin 400 mg

400 mg

Film-coated tablets Oral

Bonoq 400 mg

400 mg

Film-coated tablets Oral

Crispin 400 mg

400 mg

Film-coated tablets Oral

Bonoq 400 mg

400 mg

Film-coated tablets Oral

Crispin 400 mg

400 mg

Film-coated tablets Oral

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

Bonoq 400 mg

400 mg

Film-coated tablets Oral

Crispin 400 mg

400 mg

Film-coated tablets Oral

Blister

Blister

Blister

Blister

Blister

Blister

Blister

Blister

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

1, 3, 5, 7, 10, 14, 20,
40, 50, 100

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ANNEX II

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

Article 30 Referral for Calcichew-D3 mite (and related names) Chewable tablets (Calcium 500 mg plus chole-
calciferol 5 µg)

Member State

MAH

Invented name

Strength

Pharmaceutical form Route of administration

Packaging

Package size

Belgium

Christiaens Pharma

Steovit-D3
500 mg/200 I.E

500 mg/5 µg

Chewable tablet Oral

Bottle:
Polyethylene (PEHD)
(*) Unit dose (blister):
PVC/PVDC/PE

Bottle:
30, 60, 100
(*) Unit dose

Denmark

Nycomed Danmark A/S

Calcichew-D3

500 mg/5 µg

Chewable tablet Oral

Polyethylene (PEHD) bottle

100

Finland

Italy

Oy Leiras Finland Ab

Calcichew-D3 purutabletti

500 mg/5 µg

Chewable tablet Oral

Polyethylene (PEHD) bottle

20, 30, 60, 90, 100, 120

SPA Societá Prodotti
Antibiotici S.p.a

Calciospa-D3

500 mg/5 µg

Chewable tablet Oral

Polyethylene (PEHD) bottle

20, 30, 60, 90, 100, 120

Luxembourg

Christiaens Pharma

Netherlands

Christiaens B.V

Steovit-D3
500 mg/200 I.E.

Calcichew-D3
500 mg/200 I.E

500 mg/5 µg

Chewable tablet Oral

Polyethylene (PEHD) bottle

30, 60, 100

500 mg/5 µg

Chewable tablet Oral

Polyethylene (PEHD) bottle

90

Norway

Sweden

Nycomed Pharma AS,
Norway

Nycoplus Calcigran

500 mg/5 µg

Chewable tablet Oral

Polyethylene (PEHD) bottle

100

Nycomed Pharma AS,
Norway

Calcichew-D3 Mite

500 mg/5 µg

Chewable tablet Oral

Polyethylene (PEHD) bottle

20, 30, 60, 90, 100, 120, 180

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

ANNEX III

.

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Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

Austria

STADA Arzneimittel GesmbH
Heiligenstädter Straße 52/2/8
A-1190 Wien

Lisinostad

5 mg

Tablet

Oral use

Blister (PVC/Alu)

Lisinostad

10 mg

Tablet

Oral use

Blister (PVC/Alu)

Lisinostad

20 mg

Tablet

Oral use

Blister (PVC/Alu)

Belgium

Eurogenerics
Heizel Esplanade b22
B-1020 Brussel

Lisinopril EG

5 mg

Tablet

Oral use

Blister (PVC/Alu)

Lisinopril EG

20 mg

Tablet

Oral use

Blister (PVC/Alu)

Denmark

STADA Arzneimittel AG
Stadastraße 2—18
D-61118 Bad Vilbel

Cardiostad

5 mg

Tablet

Oral use

Blister (PVC/Alu)

Cardiostad

10 mg

Tablet

Oral use

Blister (PVC/Alu)

Cardiostad

20 mg

Tablet

Oral use

Blister (PVC/Alu)

Finland

STADA Arzneimittel AG
Stadastraße 2—18
D-61118 Bad Vilbel

Cardiostad

5 mg

Tablet

Oral use

Blister (PVC/Alu)

Cardiostad

10 mg

Tablet

Oral use

Blister (PVC/Alu)

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

20, 28, 30, 50, 98, 100
tablets

20, 28, 30, 50, 98, 100
tablets

20, 28, 30, 50, 98, 100
tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

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Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

Finland
(cont’d)

Germany

Cardiostad

20 mg

Tablet

Oral use

Blister (PVC/Alu)

STADA Arzneimittel AG
Stadastraße 2—18
D-61118 Bad Vilbel

Cardiostad

5 mg

Tablet

Oral use

Blister (PVC/Alu)

Cardiostad

10 mg

Tablet

Oral use

Blister (PVC/Alu)

Cardiostad

20 mg

Tablet

Oral use

Blister (PVC/Alu)

Ireland

Clonmel Healthcare
Waterford Road
Clonmel, Co.
Tipperary
Ierland

Zestan

5 mg

Tablet

Oral use

Blister (PVC/Alu)

Zestan

10 mg

Tablet

Oral use

Blister (PVC/Alu)

Zestan

20 mg

Tablet

Oral use

Blister (PVC/Alu)

Italy

Laboratori Euro Generici
Via Domenico Scarlatti 31
I-20124 Milano

Lisinopril EG

5 mg

Tablet

Oral use

Blister (PVC/Alu)

Lisinopril EG

20 mg

Tablet

Oral use

Blister (PVC/Alu)

Netherland

Centrafarm Services BV
Nieuwe Donk 9
4879 Etten-Leur
Nederland

Lisinopril CF

5 mg

Tablet

Oral use

Blister (PVC/Alu)

Lisinopril CF

10 mg

Tablet

Oral use

Blister (PVC/Alu)

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

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Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

Netherland
(cont’d)

Portugal

Spain

Sweden

STADA Arzneimittel AG
Stadastraße 2—18
D-61118 Bad Vilbel

STADA Arzneimittel AG
Stadastraße 2—18
D-61118 Bad Vilbel

STADA Arzneimittel AG
Stadastraße 2—18
D-61118 Bad Vilbel

Lisinopril CF

20 mg

Tablet

Oral use

Blister (PVC/Alu)

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

Lisinopril Ciclum

5 mg

Tablet

Oral use

Blister (PVC/Alu)

Lisinopril Ciclum

20 mg

Tablet

Oral use

Blister (PVC/Alu)

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

E
N

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

Lisinocic

Lisinocic

5 mg

20 mg

Lisinopril Stada

5 mg

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Blister (PVC/Alu)

60, 500 tablets

Blister (PVC/Alu)

60, 500 tablets

Blister (PVC/Alu)

Lisinopril Stada

10 mg

Tablet

Oral use

Blister (PVC/Alu)

Lisinopril Stada

20 mg

Tablet

Oral use

Blister (PVC/Alu)

United Kingdom

STADA Arzneimittel AG
Stadastraße 2—18
D-61118 Bad Vilbel

Lisinopril

5 mg

Tablet

Oral use

Blister (PVC/Alu)

Lisinopril

10 mg

Tablet

Oral use

Blister (PVC/Alu)

Lisinopril

20 mg

Tablet

Oral use

Blister (PVC/Alu)

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

14, 20, 28, 30, 50, 56, 60, 98,
100, 150, 200, 250, 300, 400,
500, 1 000 tablets

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

ANNEX IV

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package size

Austria

Tyrol Pharma GmbH
Biochemiestraße 10
Kundl
Oostenrijk

Lisinotyrol

5 mg

Tablet

Oral use

Lisinotyrol

10 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 60, 98, 100,
100 × 1, 500 tablets

Blisters (PVC/Alu) and
Bottles (PP)

28, 30, 100, 100 × 1, 250 tablets

Belgium

Denmark

Biochemie NV
Medialaan 40
Vilvoorde
België

Biochemie GmbH
Biochemiestraße 10
Kundl
Oostenrijk

Lisinotyrol

20 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 98, 100, 100 × 1,
250, 500 tablets

Lisinopril BC

5 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 60, 98, 100,
100 × 1, 250, 500 tablets

Lisinopril BC

20 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 98, 100, 100 × 1,
250, 500 tablets

Lisinopril Biochemie

5 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 60, 98, 100 × 1,
100, 250, 500 tablets

Lisinopril Biochemie

10 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

28, 30, 100, 100 × 1, 250 tablets

Lisinopril Biochemie

20 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 98, 100, 100 × 1,
250, 500 tablets

Finland

Biochemie GmbH
Biochemiestraße 10
Kundl
Oostenrijk

Lisinopril Biochemie

5 mg

Tablet

Oral use

Lisinopril Biochemie

10 mg

Tablet

Oral use

Lisinopril Biochemie

20 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

Blisters (PVC/Alu) and
Bottles (PP)

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 60, 98, 100 × 1,
100, 250, 500 tablets in blister
14, 28, 30, 56, 60, 98, 100, 250,
500 tablets in container

28, 30, 100, 100 × 1, 250 tablets
in blister
28, 30, 100, 250 tablets in
container

14, 28, 30, 56, 98, 100, 100 × 1,
250, 500 tablets in blister
14, 28, 30, 56, 98, 100, 250, 500
tablets in container

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Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package size

Luxembourg

Biochemie NV
Medialaan 40
Vilvoorde
België

Lisinopril BC

5 mg

Tablet

Oral use

Lisinopril BC

20 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

28, 56 tablets

Blisters (PVC/Alu) and
Bottles (PP)

28, 56 tablets

Netherland

Multipharma BV
Gemeenschapspolderweg 28
1382 Weesp
Nederland

MP-Lisinopril

5 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 60, 98, 100, 250,
500 tablets

MP-Lisinopril

10 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

28, 30, 100, 250 tablets

MP-Lisinopril

20 mg

Tablet

Oral use

Portugal

Biochemie GmbH
Biochemiestraße 10
A-6250 Kundl

Lisinopril Biochemie

5 mg

Tablet

Oral use

Lisinopril Biochemie

20 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 98, 100, 250, 500
tablets

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 60, 98, 100, 500,
100 × 1 (blister only) tablets

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 98, 100, 100 × 1
(blister only), 250, 500 tablets

Spain

Sweden

Laboratorios Géminis SA
Gran Via de les Corts
Catalanes 764
Barcelona
Spanje

Biochemie GmbH
Biochemiestraße 10
Kundl
Oostenrijk

Lisinopril Géminis

5 mg

Tablet

Oral use

Lisinopril Géminis

20 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

60, 500 tablets

Blisters (PVC/Alu) and
Bottles (PP)

28, 500 tablets

Lisinopril Biochemie

5 mg

Tablet

Oral use

Lisinopril Biochemie

10 mg

Tablet

Oral use

Lisinopril Biochemie

20 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 60, 98, 100, 250,
500 tablets

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 60, 98, 100, 250,
500 tablets

Blisters (PVC/Alu) and
Bottles (PP)

14, 28, 30, 56, 60, 98, 100, 250,
500 tablets

United Kingdom Multipharma BV

Lisinopril

5 mg

Tablet

Oral use

Gemeenschapspolderweg 28
1382 Weesp
Nederland

Lisinopril

10 mg

Tablet

Oral use

Lisinopril

20 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

28 tablets

Blisters (PVC/Alu) and
Bottles (PP)

28 tablets

Blisters (PVC/Alu) and
Bottles (PP)

28 tablets

.

.

2
6
3
2
0
0
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

7
7
/
1
5

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package size

Norway

Biochemie GmbH
Biochemiestraße 10
Kundl
Oostenrijk

Lisinopril Biochemie

5 mg

Tablet

Oral use

Lisinopril Biochemie

10 mg

Tablet

Oral use

Lisinopril Biochemie

20 mg

Tablet

Oral use

Blisters (PVC/Alu) and
Bottles (PP)

30, 100, 250 tablets

Blisters (PVC/Alu) and
Bottles (PP)

30, 100, 250 tablets

Blisters (PVC/Alu) and
Bottles (PP)

100, 250 tablets

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

ANNEX V

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Bristol-Myers Squibb GesmbH
Columbusgasse 4
A-1101 Wien

Belgium

Denmark

Finland

Bristol-Myers Squibb Belgium SPRL/BVBA
Chaussée de La Hulpe, 185
B-1170 Bruxelles

Bristol-Myers Squibb AB
Gustavslundsvägen 12
Box 15200
S-167 15 Bromma

Bristol-Myers Squibb AB
Gustavslundsvägen 12
Box 15200
S-167 15 Bromma

Pravachol

Pravachol

Pravachol

Selipran

Selipran

Selipran

Pravasine

Pravasine

Pravasine

Pravachol

Pravachol

Pravachol

Pravachol

Pravachol

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

20 mg

40 mg

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C

7
7
/
1
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
6
3
2
0
0
4

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

France

Germany

Bristol-Myers Squibb
1, parvis de La Défence
F-92800 Puteaux

Bristol-Myers Squibb GmbH
Sapporobogen 6—8
D-80809 München

Greece

Iceland

Ireland

Italy

Bristol-Myers Squibb EPE
102 Tatoiou and Kolokotroni Sreet
GR-14671 Nea Erythrea Attikis

Bristol-Myers Squibb AB
Gustavslundsvägen 12
Box 15200
S-167 15 Bromma

Bristol-Myers Squibb Pharmaceuticals Ltd
Watery Lane
Swords
Co. Dublin
Ireland

Bristol-Myers Squibb, Srl
Via Virgilio Maroso, 50
I-00142

Elisor

Elisor

Elisor

Pravasin

Pravasin

Pravasin

Pravasin Protect

Pravasin Protect

Pravasin Protect

Selip

Selip

Liprevil

Liprevil

Liprevil

Pravachol

Pravachol

Pravachol

Pravachol

Pravachol

Lipostat

Lipostat

Lipostat

Selectin

Selectin

Selectin

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

10 mg

20 mg

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

20 mg

40 mg

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

.

.

2
6
3
2
0
0
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

7
7
/
1
7

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Luxembourg

Netherland

Norway

Portugal

Spain

Sweden

Bristol-Myers Squibb Belgium SPRL/BVBA
Chaussée de La Hulpe, 185
B-1170 Bruxelles

Bristol-Myers Squibb BV
Vijzelmolenlaan 9
3447 GX Woerden
Nederland

Bristol-Myers Squibb AB
Gustavslundsvägen 12
Box 15200
S-167 15 Bromma

Bristol-Myers Squibb
Farmacêutica Portuguesa, Lda
Edifício Fernão de Magalhães — Quinta da Fonte —
Porto Salvo
P-2780 730 Paço de Arcos

Bristol-Myers Squibb SL
c/ Almansa, 101
E-28040 Madrid

Bristol-Myers Squibb AB
Gustavslundsvägen 12
Box 15200
S-167 15 Bromma

United Kingdom

Bristol-Myers Squibb Pharmaceuticals Ltd
141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

Pravasine

Pravasine

Pravasine

Selektine

Selektine

Selektine

Pravachol

Pravachol

Pravacol

Pravacol

Pravacol

Pravasin

Pravasin

Bristacol

Bristacol

Bristacol

Lipemol

Lipemol

Lipemol

Pravachol

Pravachol

Lipostat

Lipostat

Lipostat

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

20 mg

40 mg

10 mg

20 mg

40 mg

10 mg

20 mg

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

20 mg

40 mg

10 mg

20 mg

40 mg

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C

7
7
/
1
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
6
3
2
0
0
4