Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 January to 15 February 2002 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2002-02-22
Institutions: European Commission
Subjects: market approval, marketing, poultry, veterinary drug

C 49/6

EN

Official Journal of the European Communities

22.2.2002

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

6.2.2002

Ibaflin

Intervet International BV
Wim de K(cid:246)rverstraat 35
5831 AN Boxmeer
Nederland

EU/2/00/022/001a,
001b, 002a, 002b, 003a,
003b, 004a, 004b, 005,
006, 007, 008

8.2.2002

6.2.2002

Metacam

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/007-008

8.2.2002

(cid:151) Suspension of a marketing authorisation (Article 40 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

29.1.2002

Econor

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

EU/2/98/010/001-024

31.1.2002

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 January to 15 February 2002

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

(2002/C 49/03)

(cid:151) Issuing, maintenance or modification of a national marketing authorisation

Date of the
becision

Name(s) of the
medicinal product

Holder(s)
of the marketing
authorisation

Member State
concerned

Date of
notification

4.2.2002

Avinew

See Annex

See Annex

5.2.2002

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

22.2.2002

EN

Official Journal of the European Communities

C 49/7

LIST OF THE PHARMACEUTICAL FORMS, STRENGTHS, ROUTES OF ADMINISTRATION, PACKAGING
AND PACKAGE SIZES OF THE VETERINARY MEDICINAL PRODUCT IN THE MEMBER STATES

ANNEX

Marketing authorisation holder (name and address)

Member State reference: Merial

17, rue Bourgelat
F-69002 Lyon

Member States concerned:

AUSTRIA

Marketing authorisation holder:

Merial
17, rue Bourgelat
F-69002 Lyon

BELGIUM

Merial Belgium SA/NV
243 Bd Sylvain Dupuislaan
B-1070 Brussels

FINLAND

Merial
17, rue Bourgelat
F-69002 Lyon

GERMANY

Merial GmbH
Am S(cid:246)ldnermoos 6
D-85399 Hallbergmoos

GREECE

Merial
17, rue Bourgelat
F-69002 Lyon

IRELAND

Merial Animal Health Limited
PO Box 327
Sandringham House
Harlow Business Park
Essex CM19 5TG
United Kingdom

LUXEMBURG

Merial Belgium SA/NV
243 Blvd Sylvain Dupuislaan
B-1070 Brussels

NETHERLANDS

Merial BV
Bovenkerkerweg 6-8
1185 XE Amstelveen
Netherlands

PORTUGAL

Merial Portuguesa Saœde Animal, LDA
Av. Maria Lamas, Lote 19 (cid:151) BL. A Piso 2
P-2635 (cid:151) 432 Rio de Mouro

SPAIN

Merial Laboratorios SA
C/Tarragona no 161
E-08014 Barcelone

Presentations:

Trade name

Strength

Pharmaceutical form

Target species Route of administration

Packaging

Content

Package-size

Avinew

Avinew

Avinew

Avinew

Live Newcastle disease
least 5,5 log
virus, at
10 EID50 (*)

Powder for
suspension

Live Newcastle disease
least 5,5 log
virus, at
10 EID50 (*)

Powder for
suspension

Live Newcastle disease
virus, at
least 5,5 log
10 EID50 (*)

Powder for
suspension

Live Newcastle disease
virus, at
least 5,5 log
10 EID50 (*)

Powder for
suspension

Chickens

Chickens

Chickens

Chickens

Ocular use
Respiratory use
Oral use

Ocular use
Respiratory use
Oral use

Ocular use
Respiratory use
Oral use

Ocular use
Respiratory use
Oral use

Bottle
(glass)

Bottle
(glass)

Bottle
(glass)

Bottle
(glass)

(1 000 doses)

1 vial

(1 000 doses)

10 vials

(2 000 doses)

1 vial

(2 000 doses)

10 vials

(*) EID50: 50 % embryo-infective dose. The virus titre to produce infection in 50 % of the embryos inoculated.