Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2017 to 31 October 2017 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2017-12-01
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2017410EN.01000501.xml










1.12.2017   


EN


Official Journal of the European Union


C 410/5





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2017 to 31 October 2017
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2017/C 410/02)






—



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




5.10.2017


Lincocin and its associated names


Lincomycin


See Annex I


See Annex I


9.10.2017






(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 veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States












Member State EU/EEA


Marketing authorisation holder


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




Belgium


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


Lincocin 40 %


Lincomycin (as lincomycin hydrochloride)


400 mg/g


Powder for oral solution


Pigs, poultry (broilers)


Oral use (via drinking water)




Denmark


Zoetis Finland Oy
Tietokuja 4
00330 Helsinki
Finland


Lincocin Vet


Lincomycin hydrochloride


400 mg/g


Powder for oral solution


Pigs


Oral




France


Zoetis France
10 rue Raymond David
92240 Malakoff
France


LINCOCINE POUDRE SOLUBLE


Lincomycin hydrochloride


400 mg/g


Powder for oral solution


Pigs, chickens


Oral




Germany


Zoetis Deutschland GmbH
Schellingstr. 1
D-10785 Berlin
Germany


Albiotic Pulver 400 mg/g zum Eingeben über das Trinkwasser für Schweine


Lincomycin hydrochloride


470,6  mg lincomycin HCl/g (corresponding to 400 mg lincomycin/g)


powder for use in drinking water


Pigs


Oral




Hungary


Zoetis Hungary Kft.
Budapest, Alkotás u. 53., 1123 Hungary


Lincocin 400 mg/g por belsőleges oldathoz A.U.V.


Lincomycin hydrochloride


400 mg/g


Powder for oral solution


Pigs, chickens


In drinking water use




Ireland


Zoetis Belgium S.A
2nd Floor, Building 10
Cherrywood Business Park
Loughlinstown
Co. Dublin
Ireland


Lincocin Soluble Powder


Lincomycin hydrochloride


400 mg/g


Powder for oral solution


Pigs


Oral via the drinking water




Poland


Zoetis Polska Sp. z o.o.
Postępu 17B
02-676 Warsaw
Poland


Lincocin 40 % 400 mg/g proszek do sporządzania roztworu doustnego dla świń i kur


Lincomycin (as lincomycin hydrochloride)


400 mg/g


Powder for oral solution


Pigs, chickens


In drinking water use




United Kingdom


Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London EC4A 3AE
United Kingdom


Lincocin Soluble Powder 400 mg/g Powder for Oral Solution


Lincomycin


400 mg/g


Powder for oral solution


Pigs


In drinking water use