Letifend (recombinant protein Q from Leishmania...) – Conditions or restrictions regarding supply and use - QI07A

Updated on site: 21-Sep-2017

Medication name: Letifend
ATC: QI07A
Substance: recombinant protein Q from Leishmania infantum MON-1
Manufacturer: Laboratorios LETI, S.L.U.

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

Name and address of the manufacturer of the biological active substance

3P Biopharmaceuticals, S.L.

C/ Mocholi 2, Poligono Industrial Mocholi,

Noain, 31110 Navarra

SPAIN

Name and address of the manufacturer responsible for batch release:

Laboratorios LETI, S.L.unipersonal

C/ Del Sol, 5, Poligono Industrial Norte,

Tres Cantos, 28760, Madrid

SPAIN

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.

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