Dopharma’s poultry products receive EU marketing authorisation

25-09-2012 | | |
Dopharma's poultry products receive EU marketing authorisation
Dopharma's poultry products receive EU marketing authorisation

Dutch Veterinary pharmaceutical company, Dopharma, has obtained three new marketing authorisations in the EU including two for poultry products.

Phenoxypen WSP, phenoxymethylpenicillin for the treatment of Clostridium perfringens infection in chickens, has also been approved for use in layers, with a withdrawal period for eggs of zero days.

Following an application of Dopharma, early this year the European Commission adopted a Regulation establishing maximum residue limits for phenoxymethylpenicillin in eggs, valid throughout the EU. These maximum residue limits were based on the favourable opinion and the assessment report adopted by the Committee for Medicinal Products for Veterinary Use. Hereafter an application to extend the marketing authorisation of Phenoxypen WSP could be applied for. Phenoxypen WSP is available in 19 EU countries (AT, BE, BG, CZ, DE, DK (Phenoxylin), ES (Avipen), FR, GB, GR, HU, IE, IT LT, NL, PL, PT, RO and SK). Outside Europe Phenoxypen WSP is authorised in Egypt, Indonesia and Sudan.

Two entirely new products are Dozuril 25 mg/ml and Dexa-ject 2 mg/ml. Dozuril 25 mg/ml is a toltrazuril solution for the treatment of coccidiosis in pullets and broiler breeders. The withdrawal period for meat and offal is 16 days. Dozuril 25 mg/ml is available in 14 EU countries (BE, BG, DK, EE, FR, DE, GR, HU, IE, LV, LT, NL, PL, RO).