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Locatim (Serinucoli) (Bovine concentrated lactoserum containing...) – Conditions or restrictions regarding supply and use - QI02AT01

Updated on site: 09-Feb-2018

Medication name: Locatim (Serinucoli)
ATC: QI02AT01
Substance: Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin
Manufacturer: Biokema Anstalt

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

Biokema SA

Chemin de la Chatanérie 2 1023 Crissier-Lausanne SWITZERLAND

Name and address of the manufacturer responsible for batch release

Merial Laboratoire Porte des Alpes Rue de l’Aviation

69800 Saint Priest FRANCE

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Veterinary medicinal product subject to prescription.

According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:

a)the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.

b)the disease to which the product is intended to confer immunity is largely absent from the territory in question.

C.STATEMENT OF THE MRLs

The active substance being a principle of biological origin intended to produce passive immunity is not within the scope of Regulation (EC) No 470/2009.

The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.

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