# C_2006176EN.01002401.xml

| 28.7.2006 | EN | Official Journal of the European Union | C 176/24 |
| --- | --- | --- | --- |

28.7.2006

EN

Official Journal of the European Union

C 176/24

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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))

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1

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 | Date of notification |
| --- | --- | --- | --- | --- |
| 23.6.2006 | Micotil | See Annex I | See Annex I | 23.6.2006 |
| 27.6.2006 | Tysabri | Elan Pharma International Ltd. |
| Monksland |
| Athlone |
| County Westmeath |
| Ireland |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

23.6.2006

Micotil

See Annex I

See Annex I

23.6.2006

27.6.2006

Tysabri

Elan Pharma International Ltd.

Monksland

Athlone

County Westmeath

Ireland

This Decision is addressed to the Member States

28.6.2006

27.6.2006

Kaletra

| Abbott Laboratories Ltd |
| --- |
| Queenborough |
| Kent ME11 5EL |
| United Kingdom |

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

This Decision is addressed to the Member States

29.6.2006

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

1

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

2

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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

| Member State | Marketing Authorisation Holder | Product trade name | Strength | Pharmaceu-tical form | Animal species | Frequency | Recommended dose
  Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Boehringer Ingelheim Vetmedica GmbH |
| Binger Strasse 173 |
| D-55216 Ingelheim |

Member State

Marketing Authorisation Holder

Product trade name

Strength

Pharmaceu-tical form

Animal species

Frequency

Recommended dose

Route of administration

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 |

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 |

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 producing milk for human consumption

Single dose

1 ml for 30 kg bw (i.e. 10 mg of tilmicosin/kg bw)

subcutaneous use

France

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

Lilly France

13, rue Pages

F-92158 Suresnes cedex

Paris

Micotil 300

300 mg/ml

Solution for injection

Bovine

Single dose

10 mg/kg bw

subcutaneous use

Germany

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

Lilly Deutschland GmbH

Abt. ELANCO Animal Health

Teichweg 3

D-35396 Gießen

Micotil 300

300 mg/ml

Solution for injection

Cattle (not to be used in lactating cows)

Single dose

10 mg tilmicosin per kg bw, corresponding to 1 ml Micotil 300 per 30 kg bw

subcutaneous use

Greece

| ELANCO ELLAS |
| --- |
| Messogion 335 Av, |
| GR-15231 Athens |

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

Hungary

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

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

Ireland

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

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 (equivalent to 10 mg tilmicosin per kg bw). |
| --- | --- |

1ml Micotil per 30 kg bw (equivalent to 10 mg tilmicosin 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) |
| --- | --- |

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 |

Eli Lilly Italia S.p.A

Elanco Animal Health

Via Gramsci, 733

Sesto Fiorentino

I-50019 Firenze

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

Netherlands

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

Eli Lilly Nederland B.V.

Postbus 379

3990 GD Houten

Nederland

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

Poland

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

Eli Lilly (Suisse) S.A.

ul. Stawki no. 2, 21 pietro

00-193 Warsaw

Polska

Micotil 300

300 mg/ml

Solution for injection

Bovine

Single dose

1 ml/30 kg bw

subcutaneous use

Portugal

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

Lilly Farma — Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 4 — piso 3

Arquiparque — Miraflores

P-1495-131 Algés

Micotil

300 mg/ml

Solution for injection

Calves

Single dose

10 mg tilmicosin per kg bw (1ml per 30 kg bw)

subcutaneous use

Slovak Republic

| Eli Lilly Regional Operations GmbH |
| --- |
| Oblina 54 |
| 90027 Bernolakova |
| Slovenská republika |

Eli Lilly Regional Operations GmbH

Oblina 54

90027 Bernolakova

Slovenská republika

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.

Slovenia

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

Iris mednarodna trgovina d.o.o

Cesta v Gorice 8,

SLO-1000 Ljubljana

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

Spain

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

Lilly S.A.

Elanco Valquimica S.A.

Avda. de la Industria, 30

E-28108 Alcobendas

(Madrid)

Micotil 300

300 mg/ml

Solution for injection

Cattle

Single dose

10 mg tilmicosin/kg bw

subcutaneous use

United Kingdom

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

Eli Lilly Industries Ltd

Elanco Animal Health

Kingsclere Road

Basingtstoke

Hampshire

RG21 6XA

United Kingdom

Micotil

300 mg/ml

Solution for injection

Cattle

Sheep

(over 15kg)

Single dose

Sheep:

| | 10 mg/kg bw |
| --- | --- |

10 mg/kg bw

Cattle:

| | Pneumonia: 10 mg/kg bw |
| --- | --- |

Pneumonia: 10 mg/kg bw

Interdigital necrobacillosis:

| | 5 mg/kg bw |
| --- | --- |

5 mg/kg bw

subcutaneous use

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