Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 September 2002 to 15 October 2002 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council)
Date: 2002-10-25
Institutions: European Commission
Subjects: market approval, marketing, medicinal product, pharmaceutical legislation, pharmaceutical product, preparation for market

25.10.2002

EN

Official Journal of the European Communities

C 258/7

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

11.10.2002 Nespo

14.10.2002 Remicade

Dompé Biotec SpA
Via San Martino, 12
I-20122 Milano

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

Number of
the entry in
the Community register

Date of
notification

EU/1/01/184/001-032

15.10.2002

EU/1/99/116/001-003

16.10.2002

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

Accepted

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

30.9.2002

Quadrisol

2.10.2002

Eurican Herpes 205

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Merial
17, rue Bourgelat
F-69002 Lyon

Number of
the entry in
the Community register

Date of
notification

EU/2/97/005/004

2.10.2002

EU/2/01/029/003

4.10.2002

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 September 2002 to 15 October 2002

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) of the European Parliament and of the Council
or Article 38 of Directive 2001/82/EC (2) of the European Parliament and of the Council)

— Issuing, maintenance or modification of a national marketing authorisation

(2002/C 258/03)

Date of the decision

Name(s) of the
medicinal product

Holder(s) of the
marketing authorisation

Member State concerned

Date of
notification

30.9.2002

Actilyse

See Annex

See Annex

2.10.2002

15.10.2002

Sibutramine

See Annex

See Annex

16.10.2002

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

C 258/8

EN

Official Journal of the European Communities

25.10.2002

ANNEX

LIST OF THE INVENTED NAMES OF THE MEDICINAL PRODUCTS, MARKETING AUTHORISATION
HOLDERS, STRENGTHS, PHARMACEUTICAL FORMS, ROUTE OF ADMINISTRATION, PACKAGING AND
PACKAGE SIZES

SIBUTRAMINE CONTAINING MEDICINAL PRODUCTS WITH MARKETING AUTHORISATION IN THE MEMBER
STATES

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
Form

Route of adminis-
tration

Packaging

Package size

AUSTRIA

Abbott Ges.mbH
Diefenbachgasse 35
A-1150 Wien

Abbott Ges.mbH
Diefenbachgasse 35
A-1150 Wien

Abbott Ges.mbH
Diefenbachgasse 35
A-1150 Wien

Abbott Ges.mbH
Diefenbachgasse 35
A-1150 Wien

Reductil

10 mg

Capsule

Oral use

Reductil

15 mg

Capsule

Oral use

Meridia

10 mg

Capsule

Oral use

Meridia

15 mg

Capsule

Oral use

BELGIUM

Abbott SA
Parc Scientifique
2, rue du Bosquet
B-1348 Ottignies — LLN

Reductil

10 mg

Capsule

Oral use

Abbott SA
Parc Scientifique
2, rue du Bosquet
B-1348 Ottignies — LLN

Reductil

15 mg

Capsule

Oral use

DENMARK

Abbott Scandinavia AB
PO Box 509
S-169 29 Solna

Reductil

10 mg

Capsule, hard

Oral use

Abbott Scandinavia AB
PO Box 509
S-169 29 Solna

Reductil

15 mg

Capsule, hard

Oral use

FINLAND

Abbott Scandinavia AB
PO Box 509
S-169 29 Solna

Reductil

10 mg

Capsule

Oral use

Abbott Scandinavia AB
PO Box 509
S-169 29 Solna

Reductil

15 mg

Capsule

Oral use

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

28, 56, 98
28 (clinic)
280 (10 × 28)

28, 56, 98
28 (clinic)
280 (10 × 28)

28, 56, 98
28 (clinic)
280 (10 × 28)

28, 56, 98
28 (clinic)
280 (10 × 28)

28, 56, 98

Hospital pack:
28
280

28, 56, 98

Hospital pack:
28
280

28, 56, 98

Hospital pack:
28
280

28, 56, 98

Hospital pack:
28
280

28, 56, 98

Hospital pack:
28
280

28, 56, 98

Hospital pack:
28
280

25.10.2002

EN

Official Journal of the European Communities

C 258/9

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
Form

Route of adminis-
tration

Packaging

Package size

FRANCE

Knoll France
49, avenue Georges-
Pompidou
F-92200 Levallois

Knoll France
49, avenue Georges-
Pompidou
F-92200 Levallois

Sibutral

10 mg

Capsule, hard

Oral use

Sibutral

15 mg

Capsule, hard

Oral use

GERMANY

Abbott GmbH & Co. KG
Max-Planck-Ring 2
D-65205 Wiesbaden

Reductil

10 mg

Capsule, hard

Oral use

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Abbott GmbH & Co. KG
Max-Planck-Ring 2
D-65205 Wiesbaden

Reductil

15 mg

Capsule, hard

Oral use

Blister
(PVC/PDVC)

Abbott GmbH & Co. KG
Max-Planck-Ring 2
D-65205 Wiesbaden

Reduxade

10 mg

Capsule, hard

Oral use

Blister
(PVC/PDVC)

Abbott GmbH & Co. KG
Max-Planck-Ring 2
D-65205 Wiesbaden

Reduxade

15 mg

Capsule, hard

Oral use

Blister
(PVC/PDVC)

Abbott GmbH & Co. KG
Max-Planck-Ring 2
D-65205 Wiesbaden

Zelium

10 mg

Capsule

Oral use

Blister
(PVC/PDVC)

Abbott GmbH & Co. KG
Max-Planck-Ring 2
D-65205 Wiesbaden

Zelium

15 mg

Capsule, hard

Oral use

Blister
(PVC/PDVC)

28, 56, 98

Hospital pack:
28
280

28, 56, 98

Hospital pack:
28
280

Calendar pack:
28, 56, 98

Hospital pack
(calendar pack):
28
280 (10 × 28)

Calendar pack:
28, 56, 98

Hospital pack
(calendar pack):
28
280 (10 × 28)

Calendar pack:
28, 56, 98

Hospital pack
(calendar pack):
28
280 (10 × 28)

Calendar pack:
28, 56, 98

Hospital pack
(calendar pack):
28
280 (10 × 28)

Calendar pack:
28, 56, 98

Hospital pack
(calendar pack):
28
280 (10 × 28)

Calendar pack:
28, 56, 98

Hospital pack
(calendar pack):
28
280 (10 × 28)

GREECE

Abbott Laboratories
Hellas SA
512 Vouliagmenis Ave
GR-174 56 Alimos-
Athens

Abbott Laboratories
Hellas SA
512 Vouliagmenis Ave
GR-174 56 Alimos-
Athens

Reductil

10 mg

Capsule, hard

Oral use

Blister
(PVC/PDVC)

28, 56, 98, 280

Reductil

15 mg

Capsule, hard

Oral use

Blister
(PVC/PDVC)

28, 56, 98, 280

C 258/10

EN

Official Journal of the European Communities

25.10.2002

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
Form

Route of adminis-
tration

Packaging

Package size

IRELAND

Abbott Laboratories
Ireland
1 Broomhill Business
Park
Tallaght
Dublin 24
Ireland

Abbott Laboratories
Ireland
1 Broomhill Business
Park
Tallaght
Dublin 24
Ireland

Reductil

10 mg

Capsule

Oral use

Blister
(PVC/PDVC)

Reductil

15 mg

Capsule

Oral use

Blister
(PVC/PDVC)

Calendar pack:
28, 56, 98

Hospital pack
(calendar pack):
28
280 (10 × 28)

Calendar pack:
28, 56, 98

Hospital pack
(calendar pack):
28
280 (10 × 28)

ITALY

Knoll Deutschland GmbH
Rathausplatz 10—12
D-67059 Ludwigshafen

Reductil

10 mg

Capsule

Oral use

Blister
(PVC/PDVC)

28, 56, 98, 280

Knoll Deutschland GmbH
Rathausplatz 10—12
D-67059 Ludwigshafen

Reductil

15 mg

Capsule

Oral use

Blister
(PVC/PDVC)

28, 56, 98, 280

Bracco SpA
Via E. Folli, 50
I-20134 Milano

Bracco SpA
Via E. Folli, 50
I-20134 Milano

Abbott SpA
Via Pontina km. 52
I-04010 Campoverde di
Aprilia, LT

Abbott SpA
Via Pontina km. 52
I-04010 Campoverde di
Aprilia, LT

Abbott SA
Parc Scientifique
2, rue du Bosquet
B-1348 Ottignies — LLN

Abbott SA
Parc Scientifique
2, rue du Bosquet
B-1348 Ottignies — LLN

Abbott BV
PO Box 727
2130 AS Hoofddorp
Nederland

Abbott BV
PO Box 727
2130 AS Hoofddorp
Nederland

Ectiva

10 mg

Capsule

Oral use

Blister
(PVC/PDVC)

28, 56, 98, 280

Ectiva

15 mg

Capsule

Oral use

Blister
(PVC/PDVC)

28, 56, 98, 280

Reduxade

10 mg

Capsule

Oral use

Blister
(PVC/PDVC)

28, 56, 98, 280

Reduxade

15 mg

Capsule

Oral use

Blister
(PVC/PDVC)

28, 56, 98, 280

Reductil

10 mg

Capsule

Oral use

Blister
(PVC/PDVC)

28, 56, 98, 280

Reductil

15 mg

Capsule

Oral use

Blister
(PVC/PDVC)

28, 56, 98, 280

Reductil

10 mg

Capsule, hard

Oral use

Blister
(PVC/PDVC)

28 (2 × 14)

Reductil

15 mg

Capsule, hard

Oral use

Blister
(PVC/PDVC)

28 (2 × 14)

LUXEMBOURG

NETHERLANDS

25.10.2002

EN

Official Journal of the European Communities

C 258/11

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
Form

Route of adminis-
tration

Packaging

Package size

PORTUGAL

Reductil

15 mg

Capsule, hard

Oral use

Reductil

10 mg

Capsule, hard

Oral use

Zelium

15 mg

Capsule, hard

Oral use

Zelium

10 mg

Capsule, hard

Oral use

Abbott Laboratórios, Lda
Rua Cidade de Córdova,
1-A
Alfragide
P-2720-100 Amadora

Abbott Laboratórios, Lda
Rua Cidade de Córdova,
1-A
Alfragide
P-2720-100 Amadora

Abbott Laboratórios, Lda
Rua Cidade de Córdova,
1-A
Alfragide
P-2720-100 Amadora

Abbott Laboratórios, Lda
Rua Cidade de Córdova,
1-A
Alfragide
P-2720-100 Amadora

SPAIN

Abbott Laboratories, SA
Josefa Valcárcel, 48
E-28027 Madrid

Reductil

15 mg

Capsule

Oral use

Abbott Laboratories, SA
Josefa Valcárcel, 48
E-28027 Madrid

Reductil

10 mg

Capsule

Oral use

SWEDEN

Abbott Scandinavia AB
PO Box 509
S-169 29 Solna

Reductil

10 mg

Capsule

Oral use

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Blister
(PVC/PDVC)

Abbott Scandinavia AB
PO Box 509
S-169 29 Solna

Reductil

15 mg

Capsule

Oral use

Blister
(PVC/PDVC)

28, 56, 98

Hospital pack:
28
280

28, 56, 98

Hospital pack:
28
280

28, 56, 98

Hospital pack:
28
280

28, 56, 98

Hospital pack:
28
280

28

28

Calendar pack:
28, 56, 98

Hospital pack:
28
280

Calendar pack:
28, 56, 98

Hospital pack:
28
280

UNITED
KINGDOM

Abbott Laboratories
Limited
Queenborough
ME11 5EL
United Kingdom

Abbott Laboratories
Limited
Queenborough
ME11 5EL
United Kingdom

Reductil

10 mg

Capsule, hard

Oral use

Blister

28, 30, 56, 60, 90,
98, 120, 280

Reductil

15 mg

Capsule, hard

Oral use

Blister

28, 30, 56, 60, 90,
98, 120, 280