Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 6-8 September 2016

Press release 09/09/2016

CVMP opinions on veterinary medicinal products

The Committee adopted by majority a final positive opinion for an extension of the existing authorisation for Draxxin (tulathromycin), from Zoetis Belgium SA, to include a new target species (sheep).

The Committee adopted by consensus positive opinions for a type II variation application for Draxxin relating to pharmacodynamic properties and for a type II variation application for Bovela regarding quality changes.

The Committee adopted by consensus positive opinions for type IB variation applications (subject to worksharing procedures) for:

Inflacam and Rheumocam;

Versican Plus DHPPi and Versican Plus Pi; and

Versican Plus Pi/L4, Versican Plus DHPPi/L4 and Versican Plus L4 concerning quality changes.

More information about the above mentioned medicines, including their full indication, will be published on the Agency's website.

Renewals of marketing authorisation

The Committee adopted by consensus a positive opinion for the renewal of the marketing authorisation for Inflacam. The Committee, having re-assessed the benefit-risk balance of the product, concluded that the quality, safety and efficacy continue to be appropriately demonstrated and, therefore, recommended the renewal of the marketing authorisation.

Community referrals and related procedures

The Committee started a procedure for Zanil and associated names, and generic products thereof (oxyclozanide). The matter was referred to the Committee by France under Article 35 of Directive 2001/82/EC due to concerns related to the withdrawal periods in cattle, sheep and goats.

Scientific advice

The Committee adopted one scientific advice report further to a request for:

  • Initial advice on quality, safety and efficacy issues for a new combination product for pigs.

Minor use, minor species (MUMS)/limited market

Following the Committee's review of four requests for classification under the MUMS/limited market policy, the CVMP classified:

  • A veterinary medicinal product for a urinary system indication for use in dogs as not indicated for MUMS/limited market and therefore not eligible for reduced data requirements;
  • Two antiparasitic indications in cats and one in dogs as indicated for MUMS/limited market and eligible for reduced data requirements, and classified one antiparasitic indication in cats as not indicated for MUMS/limited market and therefore not eligible for reduced data requirements. The product is not eligible for financial incentives as it is intended for use in non-food producing species (cats and dogs);
  • An antiparasitic veterinary medicinal product for use in honey bees as indicated for MUMS/limited market and eligible for reduced data requirements. The product is not eligible for financial incentives as alternative products for the same indication are available in the EU; and
  • A veterinary medicinal product for a musculoskeletal system indication for use in horses as indicated for MUMS/limited market further to a request for re-classification. The product is not eligible for financial incentives as it is intended for use in horses.

Pharmacovigilance

The Committee reviewed the PSURs for Bravecto, HALOCUR, Meloxidolor, Parvoduk, Recuvyra and Velactis and concluded that no further action or changes to their product literature were required.

Concept papers, guidelines and SOPs

Immunologicals

The Committee adopted a reflection paper on the risks that should be considered prior to the use of unauthorised vaccines in emergency situations (EMA/CVMP/IWP/49593/2013). This reflection paper has been developed to explain the risks associated with the use of such products by describing the basis by which a standard marketing authorisation is granted and outlining the risks posed for use of unauthorised vaccines where the complete data for a standard marketing authorisation (as required by Directive 2001/82/EC) are not available. The primary target group of this reflection paper are decision and policy makers with responsibility for disease control measures.

The Committee adopted a concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) (EMA/CVMP/IWP/867388/2015) for a 3-month period of public consultation.

The Committee adopted a concept paper for the revision of the note for guidance on the use of adjuvanted immunological veterinary medicinal products (EMA/CVMP/IWP/867395/2015) for a 3-month period of public consultation.

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