# C_2015396EN.01000701.xml

| 27.11.2015 | EN | Official Journal of the European Union | C 396/7 |
| --- | --- | --- | --- |

27.11.2015

EN

Official Journal of the European Union

C 396/7

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2015 to 31 October 2015

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

1

2

(2015/C 396/02)

—   Issuing, maintenance or modification of a national marketing authorisation

Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 22.10.2015 | Gutal | See Annex | See Annex | See Annex | 23.10.2015 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

22.10.2015

Gutal

See Annex

See Annex

See Annex

23.10.2015

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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

List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States

| Member State
  (EU/EEA) | Applicant | Product name | INN | Strength | Pharmaceutical
  form | Animal species | Route of
  administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Belgium | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Bulgaria | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Cyprus | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Czech Republic | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Denmark | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Estonia | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| France | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Germany | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Greece | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Hungary | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Ireland | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Italy | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Latvia | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Lithuania | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Luxembourg | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Malta | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| The Netherlands | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Poland | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Portugal | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Romania | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Slovakia | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Slovenia | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Spain | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| United Kingdom | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |

Member State

(EU/EEA)

Applicant

Product name

INN

Strength

Pharmaceutical

form

Animal species

Route of

administration

Austria

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Belgium

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Bulgaria

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Cyprus

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Czech Republic

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Denmark

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Estonia

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

France

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Germany

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Greece

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Hungary

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Ireland

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Italy

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Latvia

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Lithuania

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Luxembourg

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Malta

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

The Netherlands

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Poland

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Portugal

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Romania

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Slovakia

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Slovenia

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Spain

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

United Kingdom

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

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