Corrigendum to the 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) (OJ C 258 of 25.10.2002)
Date: 2002-11-05
Institutions: European Commission
Subjects: market approval, marketing, medicinal product, pharmaceutical legislation, pharmaceutical product, preparation for market

C 269/14

EN

Official Journal of the European Communities

5.11.2002

CORRIGENDA

Corrigendum to the 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)

(Official Journal of the European Communities C 258 of 25 October 2002)

Page 7, add the following annex:

(2002/C 269/08)

‘ANNEX

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF
ADMINISTRATION, MARKETING AUITHORISATION HOLDER, PACKAGING AND PACKAGE SIZES IN
THE MEMBER STATES

Member State

Marketing
authorisation holder

Invented
name

Strength

Pharmaceutical
form

Route of
administration

Packaging

AUSTRIA

Boehringer Ingelheim
Austria GmbH

Actilyse

20,
50 mg

BELGIUM

NV Boehringer
Ingelheim SA

Actilyse

10, 20,
50 mg

Powder and
solvent for
solution for
injection and
infusion

Powder and
solvent for
solution for
injection and
infusion

100 mg

Content
(concen-
tration)

1 mg/ml
or
2 mg/ml

Package size

1 vial with powder +
1 vial with solvent

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

1 mg/ml
or
2 mg/ml

1 vial with powder +
1 vial with solvent

DENMARK

Boehringer Ingelheim
International GmbH

Actilyse

10, 20,
50 mg

Powder and
solvent for
solution for
injection and
infusion

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

1 mg/ml
or
2 mg/ml

100 mg

FINLAND

Boehringer Ingelheim
International GmbH

Actilyse

10, 20,
50 mg

Powder and
solvent for
solution for
injection and
infusion

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

1 mg/ml
or
2 mg/ml

100 mg

FRANCE

Boehringer Ingelheim
France

Actilyse

10, 20,
50 mg

Powder and
solvent for
solution for
injection and
infusion

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

1 mg/ml
or
2 mg/ml

100 mg

1 vial with powder +
2 vials with solvent

1 vial with powder +
1 vial with solvent

1 vial with powder +
2 vials with solvent

1 vial with powder +
1 vial with solvent

1 vial with powder +
2 vials with solvent

1 vial with powder +
1 vial with solvent

1 vial with powder +
2 vials with solvent

5.11.2002

EN

Official Journal of the European Communities

C 269/15

Member State

Marketing
authorisation holder

Invented
name

Strength

Pharmaceutical
form

Route of
administration

Packaging

GERMANY

Boehringer Ingelheim
Pharma KG

Actilyse

10, 20,
50 mg

Powder and
solvent for
solution for
injection and
infusion

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

Content
(concen-
tration)

1 mg/ml
or
2 mg/ml

Package size

1 vial with powder +
1 vial with solvent

100 mg

1 vial with powder +
2 vials with solvent

GREECE

Boehringer Ingelheim
International GmbH

Actilyse

10, 20,
50 mg

IRELAND

Boehringer Ingelheim Ltd
UK

Actilyse

10, 20,
50 mg

100 mg

ITALY

Boehringer Ingelheim
Italia SpA

Actilyse

20,
50 mg

LUXEMBOURG

NV Boehringer
Ingelheim SA
Belgium

Actilyse

10, 20,
50 mg

THE
NETHERLANDS

Boehringer Ingelheim BV Actilyse

100 mg

10, 20,
50 mg

100 mg

Powder and
solvent for
solution for
injection and
infusion

Powder and
solvent for
solution for
injection and
infusion

Powder and
solvent for
solution for
injection and
infusion

Powder and
solvent for
solution for
injection and
infusion

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

1 mg/ml
or
2 mg/ml

1 vial with powder +
1 vial with solvent

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

1 mg/ml
or
2 mg/ml

1 vial with powder +
1 vial with solvent

1 vial with powder +
2 vials with solvent

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

1 mg/ml
or
2 mg/ml

1 vial with powder +
1 vial with solvent

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

1 mg/ml
or
2 mg/ml

1 vial with powder +
1 vial with solvent

1 vial with powder +
2 vials with solvent

Powder and
solvent for
solution for
injection and
infusion

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

1 mg/ml
or
2 mg/ml

1 vial with powder +
1 vial with solvent

1 vial with powder +
2 vials with solvent

PORTUGAL

Boehringer Ingelheim,
Lda

Actilyse

10, 20,
50 mg

Powder and
solvent for
solution for
injection and
infusion

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

1 mg/ml
or
2 mg/ml

1 vial with powder +
1 vial with solvent

100 mg

1 vial with powder +
2 vials with solvent

C 269/16

EN

Official Journal of the European Communities

5.11.2002

Member State

Marketing
authorisation holder

Invented
name

Strength

Pharmaceutical
form

Route of
administration

Packaging

SPAIN

Boehringer Ingelheim
International GmbH

Actilyse

10, 20,
50 mg

Powder and
solvent for
solution for
injection and
infusion

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

Content
(concen-
tration)

1 mg/ml
or
2 mg/ml

Package size

1 vial with powder +
1 vial with solvent

100 mg

SWEDEN

Boehringer Ingelheim
International GmbH

Actilyse

10, 20,
50 mg

UNITED
KINGDOM

Boehringer Ingelheim Ltd Actilyde 10, 20,
50 mg

1 vial with powder +
2 viald with solvent

1 vial with powder +
1 vial with solvent

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

1 mg/ml
or
2 mg/ml

Intravenous
use

Powder:
vial (glass)
Solvent:
vial (glass)

1 mg/ml
or
2 mg/ml

1 vial with powder +
1 vial with solvent

Powder and
solvent for
solution for
injection and
infusion

Powder and
solvent for
solution for
injection and
infusion

100 mg

1 vial with powder +
2 vials with solvent’