Bovela (modified live bovine viral diarrhoea...) – Conditions or restrictions regarding supply and use - QI02AD02

Updated on site: 09-Aug-2017

Medication name: Bovela
ATC: QI02AD02
Substance: modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9 and modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93
Manufacturer: Boehringer Ingelheim Vetmedica GmbH

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

Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Vetmedica Inc.

2621 North Belt Highway, St. Joseph, Missouri, 64506 USA

Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein GERMANY

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 active immunity is not in the scope of Regulation (EC) 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 or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.

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