Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 November 2000 to 15 December 2000 (Decisions taken pursuant to Article 14 of Directive 75/319/EEC or Article 22 of Directive 81/881/EEC)
Date: 2001-01-05
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, medicinal product, pharmaceutical legislation

5.1.2001

EN

Official Journal of the European Communities

C 2/7

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 November 2000 to 15 December 2000

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

(cid:151) Modification of a national marketing authorisation

(2001/C 2/05)

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the marketing authorisation

Member State concerned

Date of
notification

29.11.2000

29.11.2000

Bifril
Teoula
Zofepril
Zopranol

Zofenil
Zopranol
Bifril

See Annex I

See Annex I

1.12.2000

See Annex II

See Annex II

30.11.2000

(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).

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 I

Member State

Marketing author-
isation holder

Austria

MIOL SA (1)

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)

12

48

14

28

12

14

28

14

28

56

14

28

56

C 2/8

EN

Official Journal of the European Communities

5.1.2001

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Belgium

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

Denmark

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

Finland

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

14

28

48

14

28

14

28

56

14

28

56

12

48

14

28

12

14

28

14

28

56

14

28

56

12

48

14

28

12

5.1.2001

EN

Official Journal of the European Communities

C 2/9

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Finland
(cont(cid:146)d)

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

France

MIOL SA

Teoula

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Teoula

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Teoula

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Teoula

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Teoula

15 mg

Film-coated tablet

Oral use

MIOL SA

Teoula

15 mg

Film-coated tablet

Oral use

MIOL SA

Teoula

15 mg

Film-coated tablet

Oral use

MIOL SA

Teoula

30 mg

Film-coated tablet

Oral use

MIOL SA

Teoula

30 mg

Film-coated tablet

Oral use

MIOL SA

Teoula

30 mg

Film-coated tablet

Oral use

MIOL SA

Teoula

60 mg

Film-coated tablet

Oral use

MIOL SA

Teoula

60 mg

Film-coated tablet

Oral use

MIOL SA

Teoula

60 mg

Film-coated tablet

Oral use

Germany

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

14

28

14

28

56

14

28

56

12

48

14

28

12

14

28

14

28

56

14

28

56

30

50

100

50-unit dose

30

50

100

50-unit dose

C 2/10

EN

Official Journal of the European Communities

5.1.2001

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Germany
(cont(cid:146)d)

MIOL SA

Bifril

30 mg

Film-coated tablet

Oral use

MIOL SA

Bifril

30 mg

Film-coated tablet

Oral use

Greece

MIOL SA

Bifril

30 mg

Film-coated tablet

Oral use

MIOL SA

Bifril

30 mg

Film-coated tablet

Oral use

MIOL SA

Bifril

60 mg

Film-coated tablet

Oral use

MIOL SA

Bifril

60 mg

Film-coated tablet

Oral use

MIOL SA

Bifril

60 mg

Film-coated tablet

Oral use

MIOL SA

Bifril

60 mg

Film-coated tablet

Oral use

Menarini Hellas
SA (2)

Menarini Hellas
SA

Menarini Hellas
SA

Menarini Hellas
SA

Menarini Hellas
SA

Menarini Hellas
SA

Menarini Hellas
SA

Menarini Hellas
SA

Menarini Hellas
SA

Menarini Hellas
SA

Menarini Hellas
SA

Menarini Hellas
SA

Menarini Hellas
SA

Zofepril

7,5 mg

Film-coated tablet

Oral use

Zofepril

7,5 mg

Film-coated tablet

Oral use

Zofepril

7,5 mg

Film-coated tablet

Oral use

Zofepril

7,5 mg

Film-coated tablet

Oral use

Zofepril

15 mg

Film-coated tablet

Oral use

Zofepril

15 mg

Film-coated tablet

Oral use

Zofepril

15 mg

Film-coated tablet

Oral use

Zofepril

30 mg

Film-coated tablet

Oral use

Zofepril

30 mg

Film-coated tablet

Oral use

Zofepril

30 mg

Film-coated tablet

Oral use

Zofepril

60 mg

Film-coated tablet

Oral use

Zofepril

60 mg

Film-coated tablet

Oral use

Zofepril

60 mg

Film-coated tablet

Oral use

Ireland

MIOL SA

Bifril

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Bifril

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Bifril

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Bifril

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Bifril

15 mg

Film-coated tablet

Oral use

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

30

50

100

50-unit dose

30

50

100

50-unit dose

12

48

14

28

12

14

28

14

28

56

14

28

56

12

48

14

28

12

5.1.2001

EN

Official Journal of the European Communities

C 2/11

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Ireland
(cont(cid:146)d)

Italy

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

Menarini
Industrie Sud
Srl (3)
Menarini
Industrie Sud
Srl
Menarini
Industrie Sud
Srl
Menarini
Industrie Sud
Srl
Menarini
Industrie Sud
Srl
Menarini
Industrie Sud
Srl
Menarini
Industrie Sud
Srl
Menarini
Industrie Sud
Srl
Menarini
Industrie Sud
Srl
Menarini
Industrie Sud
Srl
Menarini
Industrie Sud
Srl
Menarini
Industrie Sud
Srl
Menarini
Industrie Sud
Srl

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

Zofepril

7,5 mg

Film-coated tablet

Oral use

Zofepril

7,5 mg

Film-coated tablet

Oral use

Zofepril

7,5 mg

Film-coated tablet

Oral use

Zofepril

7,5 mg

Film-coated tablet

Oral use

Zofepril

15 mg

Film-coated tablet

Oral use

Zofepril

15 mg

Film-coated tablet

Oral use

Zofepril

15 mg

Film-coated tablet

Oral use

Zofepril

30 mg

Film-coated tablet

Oral use

Zofepril

30 mg

Film-coated tablet

Oral use

Zofepril

30 mg

Film-coated tablet

Oral use

Zofepril

60 mg

Film-coated tablet

Oral use

Zofepril

60 mg

Film-coated tablet

Oral use

Zofepril

60 mg

Film-coated tablet

Oral use

Luxembourg

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)

14

28

14

28

56

14

28

56

12

48

14

28

12

14

28

14

28

56

14

28

56

14

28

48

56

56-unit dose

C 2/12

EN

Official Journal of the European Communities

5.1.2001

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Luxembourg
(cont(cid:146)d)

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

Portugal

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

14

28

56

56-unit dose

14

28

56

56-unit dose

14

28

56

56-unit dose

12

48

14

28

12

14

28

14

28

56

14

28

56

5.1.2001

EN

Official Journal of the European Communities

C 2/13

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Spain

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

Sweden

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

Netherland

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

12

48

14

28

12

14

28

14

28

56

14

28

56

12

48

14

28

12

14

28

14

28

56

14

28

56

15

30

50-unit dose

C 2/14

EN

Official Journal of the European Communities

5.1.2001

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Netherland
(cont(cid:146)d)

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

United
Kingdom

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

(1) MIOL SA: Menarini International Operations Luxembourg SA (cid:151) 1, Avenue de la Gare, L-1611 Luxembourg.
(2) Menarini Hellas SA: Constantinoupoleos & Dambergis, 7 (cid:151) GR-10445 Athens.
(3) Menarini Industrie Sud Srl: Via Campo di Pile (cid:151) I-67100 L’Aquila.

Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)
Calendar Blister
(PVDC/PVC/Alu)

15

30

50-unit dose

15

30

50-unit dose

15

30

50-unit dose

12

48

14

28

12

14

28

14

28

56

14

28

56

5.1.2001

EN

Official Journal of the European Communities

C 2/15

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 II

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Austria

MIOL SA (1)

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

Belgium

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

Denmark

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

12

48

14

28

12

14

28

14

28

56

14

28

56

14

28

48

14

28

14

28

56

14

28

56

12

48

14

C 2/16

EN

Official Journal of the European Communities

5.1.2001

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Denmark
(cont(cid:146)d)

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

Finland

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

France

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

28

12

14

28

14

28

56

14

28

56

12

48

14

28

12

14

28

14

28

56

14

28

56

12

48

5.1.2001

EN

Official Journal of the European Communities

C 2/17

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

France
(cont(cid:146)d)

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

Germany

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

Berlin Chemie
AG (2)

Berlin Chemie
AG

Berlin Chemie
AG

Berlin Chemie
AG

Berlin Chemie
AG

Berlin Chemie
AG

Berlin Chemie
AG

Berlin Chemie
AG

Berlin Chemie
AG

Berlin Chemie
AG

Berlin Chemie
AG

Berlin Chemie
AG

Berlin Chemie
AG

Berlin Chemie
AG

Berlin Chemie
AG

Berlin Chemie
AG

Zofenil

7,5 mg

Film-coated tablet

Oral use

Zofenil

7,5 mg

Film-coated tablet

Oral use

Zofenil

7,5 mg

Film-coated tablet

Oral use

Zofenil

7,5 mg

Film-coated tablet

Oral use

Zofenil

15 mg

Film-coated tablet

Oral use

Zofenil

15 mg

Film-coated tablet

Oral use

Zofenil

15 mg

Film-coated tablet

Oral use

Zofenil

15 mg

Film-coated tablet

Oral use

Zofenil

30 mg

Film-coated tablet

Oral use

Zofenil

30 mg

Film-coated tablet

Oral use

Zofenil

30 mg

Film-coated tablet

Oral use

Zofenil

30 mg

Film-coated tablet

Oral use

Zofenil

60 mg

Film-coated tablet

Oral use

Zofenil

60 mg

Film-coated tablet

Oral use

Zofenil

60 mg

Film-coated tablet

Oral use

Zofenil

60 mg

Film-coated tablet

Oral use

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

14

28

12

14

28

14

28

56

14

28

56

30

50

100

50-unit dose

30

50

100

50-unit dose

30

50

100

50-unit dose

30

50

100

50-unit dose

C 2/18

EN

Official Journal of the European Communities

5.1.2001

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Greece

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

15 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

30 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

MIOL SA

Zopranol

60 mg

Film-coated tablet

Oral use

Ireland

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

12

48

14

28

12

14

28

14

28

56

14

28

56

12

48

14

28

12

14

28

14

28

56

14

28

56

5.1.2001

EN

Official Journal of the European Communities

C 2/19

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Italy

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

MIOL SA

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

Bifril

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

7,5 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

15 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

30 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

60 mg

Film-coated tablet

Oral use

Luxembourg

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

12

48

14

28

12

14

28

14

28

56

14

28

56

14

28

48

56

56-unit dose

14

28

56

56-unit dose

14

28

56

56-unit dose

14

28

56

56-unit dose

C 2/20

EN

Official Journal of the European Communities

5.1.2001

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Portugal

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

Spain

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

Sweden

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

12

48

14

28

12

14

28

14

28

56

14

28

56

12

48

14

28

12

14

28

14

28

56

14

28

56

12

48

5.1.2001

EN

Official Journal of the European Communities

C 2/21

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

Sweden
(cont(cid:146)d)

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

Netherland

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

14

28

12

14

28

14

28

56

14

28

56

15

30

50-unit dose

15

30

50-unit dose

15

30

50-unit dose

15

30

50-unit dose

C 2/22

EN

Official Journal of the European Communities

5.1.2001

Member State

Marketing author-
isation holder

Trade name

Strength

Pharmaceutical form

Route of
administration

Packaging

Package size

United
Kingdom

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

7,5 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

15 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

30 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

MIOL SA

Zofenil

60 mg

Film-coated tablet

Oral use

(1) MIOL SA: Menarini International Operations Luxembourg SA (cid:151) 1, Avenue de la Gare, L-1611 Luxembourg.
(2) Berlin Chemie AG: Glienicker Weg 125, D-12489 Berlin.

Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

Calendar Blister
(PVDC/PVC/Alu)

12

48

14

28

12

14

28

14

28

56

14

28

56