Clynav (pUK-SPDV-poly2#1 DNA plasmid coding...) – Conditions or restrictions regarding supply and use - QI10AX
Updated on site: 09-Feb-2018
|Stoff:||pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins|
|Produsent:||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
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.