Clynav (pUK-SPDV-poly2#1 DNA plasmid coding...) – Conditions or restrictions regarding supply and use - QI10AX

Updated on site: 21-Sep-2017

Наименование на лекарството: Clynav
ATC: QI10AX
Вещество: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins
Производител: Elanco Europe Limited

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

Name and address of the manufacturer of the biological active substance Elanco Canada Ltd

37 McCarville Street

Charlottetown, PEI C1E 2A7 CANADA

Name and address of the manufacturer responsible for batch release

Elanco Animal Health

Eli Lilly and Company Limited, Speke Operations

Fleming road

Liverpool

L24 9LN

UNITED KINGDOM

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Veterinary medicinal product subject to prescription.

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

Коментари