Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 June 2006  to  30 June 2006 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2006-07-28
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, pharmaceutical legislation, veterinary drug

C 176/24

EN

Official Journal of the European Union

28.7.2006

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 June 2006 to 30 June 2006

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

(2006/C 176/10)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the
decision

Name(s) of the
medicinal
product

Holder(s) of the marketing
authorization

Member State concerned

23.6.2006

Micotil

See Annex I

See Annex I

Date of
notification

23.6.2006

28.6.2006

This Decision is addressed to
the Member States

This Decision is addressed to
the Member States

29.6.2006

27.6.2006

Tysabri

27.6.2006

Kaletra

Elan Pharma International Ltd.
Monksland
Athlone
County Westmeath
Ireland

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS,
ROUTES OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN
THE CONCERNED MEMBER STATES

.

.

2
8
7
2
0
0
6

Member State

Marketing Authorisation Holder

Product trade name

Strength

Pharmaceu-tical form

Animal species

Frequency

Recommended dose
Route of administration

E
N

Austria

Boehringer Ingelheim Vetmedica
GmbH
Binger Strasse 173
D-55216 Ingelheim

Micotil — Injektionslösung
für Rinder

300 mg/ml

Solution for injection

Cattle (calves and heifers)

Single dose 10 mg of tilmicosin/kg bw

subcutaneous use

Belgium

Eli Lilly Benelux
Stoofstraat 52
B-1000 Bruxelles

Micotil

300 mg/ml

Solution for injection

Cattle, sheep

Single dose 10 mg/kg bw

subcutaneous use

Czech Republic

Eli Lilly Regional Operations GmbH
Elanco Animal Health
Barichgasse 40-42
A-1030 Wien

Micotil 300 inj. ad us. vet.

300 mg/ml

Solution for injection

Young cattle (bovine)
Not for use in cows produ-
cing milk
human
consumption

for

Single dose 1 ml

for 30 kg bw (i.e.

10 mg of tilmicosin/kg bw)
subcutaneous use

France

Germany

Lilly France
13, rue Pages
F-92158 Suresnes cedex
Paris

Lilly Deutschland GmbH
Abt. ELANCO Animal Health
Teichweg 3
D-35396 Gießen

Micotil 300

300 mg/ml

Solution for injection

Bovine

Single dose 10 mg/kg bw

subcutaneous use

Micotil 300

300 mg/ml

Solution for injection

Cattle (not
lactating cows)

to be used in

Single dose 10 mg tilmicosin per kg bw,
corresponding
1 ml
Micotil 300 per 30 kg bw
subcutaneous use

to

Greece

ELANCO ELLAS
Messogion 335 Av,
GR-15231 Athens

Micotil 300

300 mg/ml

Solution for injection

Cattle, sheep

Single dose 10 mg tilmicosin/kg bw

subcutaneous use

O

f
f
i
c
i
a
l

J
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n
a
l

o
f

t
h
e

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U
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7
6
/
2
5

Member State

Marketing Authorisation Holder

Product trade name

Strength

Pharmaceu-tical form

Animal species

Frequency

Recommended dose
Route of administration

Hungary

Ireland

Eli Lilly Regional Operations GmbH
Barichgasse 40-42
A-1030 Wien

Micotil 300 Injection A.U.V.

300 mg/ml

Solution for injection

Cattle (calf)

Single dose 10 mg tilmicosin/kg bw

subcutaneous use

Eli Lilly & Company Ltd
Elanco Animal Health
Kingsclere Road
Basingstoke
Hampshire
RG21 6XA
United Kingdom

Micotil Injection

300 mg/ml

Solution for injection

Cattle and sheep

Single dose All

sheep indications

and

pneumonia in cattle:
1ml Micotil per 30 kg bw
to 10 mg tilmi-
(equivalent
cosin per kg bw).

Interdigital necrobacillosis in
cattle:
0.5 — 1 ml Micotil per
30 kg bw (equivalent to 5-
10 mg tilmicosin per kg bw)

subcutaneous use

Italy

Eli Lilly Italia S.p.A
Elanco Animal Health
Via Gramsci, 733
Sesto Fiorentino
I-50019 Firenze

Netherlands

Eli Lilly Nederland B.V.
Postbus 379
3990 GD Houten
Nederland

Poland

Portugal

Eli Lilly (Suisse) S.A.
ul. Stawki no. 2, 21 pietro
00-193 Warsaw
Polska

Lilly Farma — Produtos Farmacêu-
ticos, Lda
Rua Dr. António Loureiro Borges, 4
— piso 3
Arquiparque — Miraflores
P-1495-131 Algés

Micotil 300

300 mg/ml

Solution for injection

Cattle, sheep and rabbit

Single dose 10 mg

tilmicosin/kg

bw

(1 ml/30 kg bw)
subcutaneous use

Micotil 300

300 mg/ml

Solution for injection

Cattle and calves up to 2
years of age;
Non-lactating sheep

Single dose 10 mg tilmicosin/kg bw

subcutaneous use

Micotil 300

300 mg/ml

Solution for injection

Bovine

Single dose 1 ml/30 kg bw

subcutaneous use

Micotil

300 mg/ml

Solution for injection

Calves

Single dose 10 mg tilmicosin per kg bw

(1ml per 30 kg bw)
subcutaneous use

C

1
7
6
/
2
6

E
N

O

f
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a
l

J
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n
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t
h
e

E
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p
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a
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U
n
o
n

i

.

.

2
8
7
2
0
0
6

Member State

Marketing Authorisation Holder

Product trade name

Strength

Pharmaceu-tical form

Animal species

Frequency

Recommended dose
Route of administration

Slovak Republic

Slovenia

Spain

Eli Lilly Regional Operations GmbH
Oblina 54
90027 Bernolakova
Slovenská republika

Iris mednarodna trgovina d.o.o
Cesta v Gorice 8,
SLO-1000 Ljubljana

Lilly S.A.
Elanco Valquimica S.A.
Avda. de la Industria, 30
E-28108 Alcobendas
(Madrid)

United Kingdom Eli Lilly Industries Ltd
Elanco Animal Health
Kingsclere Road
Basingtstoke
Hampshire
RG21 6XA
United Kingdom

.

.

2
8
7
2
0
0
6

Micotil

300 mg/ml

Solution for injection

Young cattle

Single dose 10 mg Tilmicosinum/ kg bw
equivalent to 1 ml per 30 kg
bw, during 3-4 days
subcutaneous use.

Micotil 300

300 mg/ml

Solution for injection

Cattle

Micotil 300

300 mg/ml

Solution for injection

Cattle

Single dose 1 ml Micotil 300 per 30 kg
bw (10 mg tilmicosin/kg bw)
subcutaneous use

E
N

Single dose 10 mg tilmicosin/kg bw

subcutaneous use

Micotil

300 mg/ml

Solution for injection

Cattle
Sheep
(over 15kg)

Single dose

Sheep:
10 mg/kg bw

Cattle:
Pneumonia: 10 mg/kg bw

Interdigital necrobacillosis:
5 mg/kg bw

subcutaneous use

O

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E
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7
6
/
2
7