# C_2017410EN.01000501.xml

| 1.12.2017 | EN | Official Journal of the European Union | C 410/5 |
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1.12.2017

EN

Official Journal of the European Union

C 410/5

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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))

1

2

(2017/C 410/02)

| — | Issuing, maintenance or modification of a national marketing authorisation |
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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 |
| --- | --- | --- | --- | --- | --- |
| 5.10.2017 | Lincocin and its associated names | Lincomycin | See Annex I | See Annex I | 9.10.2017 |

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

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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 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 |

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

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