Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 September 2013
Press release
Veterinary
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for an extension of the existing authorisation for Comfortis (spinosad), from Eli Lilly and Company Limited concerning the addition of a new tablet strength of 180 mg with two presentations for dogs and cats.
The Committee adopted by consensus positive opinions for the following type-II-variation applications:
Annual re-assessment of marketing authorisations
The Committee adopted opinions on the annual re-assessment for Zulvac 1+8 Bovis and Coxevac, further to the evaluation of the data submitted by the marketing-authorisation holders. Since the specific obligations for Zulvac 1+8 Bovis have been fulfilled, the Committee recommended the conversion of the Community marketing authorisation from under exceptional circumstances to a normal status for this product. The Committee recommended the continuation of the Community marketing authorisations under exceptional circumstances for Coxevac.
Renewals of marketing authorisation
The Committee adopted by consensus positive opinions for the renewal of the marketing authorisations for Onsior and Easotic.The Committee, having re-assessed the benefit-risk balance of these products, concluded that the quality, safety and efficacy continue to be appropriately demonstrated and, therefore, recommended the renewal of the marketing authorisations.
Maximum residue limits
Further to the adoption of an opinion recommending the establishment of a maximum residue limit (MRL) for ivermectin in muscle in all mammalian food-producing species together with the reference to a residue level to be considered for the injection site, the European Commission requested the CVMP to review its opinion and in particular to consider alternatives to the recommended inclusion of an injection site residue limit in table 1 of the annex to Regulation (EU) No. 37/2010. The Committee, having reviewed the previous opinion and having considered the available options, agreed to revise its recommendation and adopted, by consensus, a revised positive opinion recommending the establishment of MRLs for ivermectin in all mammalian food-producing species without reference to injection-site residues in Regulation (EU) No. 37/2010. Information on residue levels at the injection site, to be taken into account for the establishment of withdrawal periods, is now provided in the European public MRL assessment report (EPMAR), which will be published following adoption of the MRLs by the European Commission and their publication in the Official Journal of the European Union.
Scientific advice
The Committee adopted five separate scientific-advice reports concerning:
Minor use minor species (MUMS) / limited markets
Following the Committee's review of three requests for classification under the MUMS / limited-markets policy, which concerned an antimicrobial product for rabbits, an immunological product for chickens, and a product for horses:
Pharmacovigilance
The Committee reviewed the PSURs for Acticam, Advocate, BTVPUR AlSap 2-4, Dicural, Halocur, Inflacam, Porcilis ColiClos, Procox, ProteqFlu, Veraflox and Zuprevo and concluded that no further action or changes to their product literature were required.
The Committee also reviewed the PSURs for Activyl and Equilis StrepE and recommended amendments to the product information to add new adverse reactions.
The Committee additionally reviewed the PSUR for Porcilis AR-T DF and recommended amendments to the product information to add new adverse reactions and to modify the precautions for use during pregnancy, lactation or lay.