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 or Article 38 of Directive 2001/82/EC)
Date: 2015-11-27
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, swine, veterinary drug








C_2015396EN.01000701.xml










27.11.2015   


EN


Official Journal of the European Union


C 396/7





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))
(2015/C 396/02)
—   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






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


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.