BTVPUR (bluetongue-virus serotype-1 antigen...) – Conditions or restrictions regarding supply and use - QI04AA02

Updated on site: 08-Feb-2018

Název léku : BTVPUR
ATC: QI04AA02
Látka: bluetongue-virus serotype-1 antigen /bluetongue-virus serotype-8 antigen
Výrobce: Merial

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

Name and address of the manufacturer of the biological active substance

MERIAL Animal Health Limited

Biological Laboratory, Ash Road,

Pirbright, Woking, Surrey GU24 0NQ

United Kingdom

MERIAL Laboratoire de Lyon Gerland 254, rue Marcel Mérieux

69342 LYON CEDEX 07 France

Name and address of the manufacturer responsible for batch release

MERIAL

Laboratory of Lyon Porte des Alpes Rue de l’Aviation,

69800 Saint-Priest France

B.CONDITIONS OR RESTRICTIONS OF REGARDING SUPPLY OR 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.

The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue.

C.STATEMENT OF THE MRLs

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

The excipients (including adjuvants) listed in section 6.1 of the SPC are either 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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