Quadrisol (vedaprofen) – Conditions or restrictions regarding supply and use - QM01AE90

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Purna Pharmaceuticals N.V.

Rijksweg 17

B-2870 Puurs

BELGIUM

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Veterinary medicinal product subject to prescription.

C.STATEMENT OF THE MRLs

The active substance in Quadrisol is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:

Pharmacologically

Marker

Animal

MRLs

Target tissues

Other provisions

active substance

residue

species

 

 

 

vedaprofen

vedaprofen

Equidae

1000 µg/kg

Kidney

 

 

 

 

100 µg/kg

Liver

 

 

 

 

50 µg/kg

Muscle

 

 

 

 

20 µg/kg

Fat

 

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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