Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 April 2017
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for Prevomax (maropitant), from Le Vet Beheer B.V., a generic anti-emetic product for the treatment and/or prevention of nausea and emesis in dogs and cats.
The Committee adopted a positive opinion for a type II variation application to add a new therapeutic indication for Activyl Tick Plus. The Committee also adopted by consensus a positive opinion for a grouped type II variation application for Suvaxyn Circo+MH RTU regarding a change to the duration of immunity, as well as a quality change.
The Committee also adopted by consensus a positive opinion for a type IB variation application (subject to a worksharing procedure), regarding quality changes, for ZULVAC 1+8 Bovis, ZULVAC 8 Ovis, ZULVAC 8 Bovis, ZULVAC 1+8 Ovis, ZULVAC 1 Ovis, ZULVAC SBV and ZULVAC 1 Bovis.
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 Cardalis. 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 concluded the referral procedure for Denagard 45% and its associated names (tiamulin hydrogen fumarate) from Elanco Animal Health (Novartis Animal Health Inc.). The matter was referred to the Committee by Germany, under Article 34 of Directive 2001/82/EC, due to divergent decisions taken by Member States resulting in discrepancies in the product information. The Committee agreed to harmonised product information for the concerned products, and adopted by consensus an opinion concluding that the marketing authorisations of the concerned products should be varied in order to amend the product information accordingly.
Maximum Residue Limits
The Committee adopted by consensus a positive opinion recommending the inclusion of alarelin in table 1 of Annex to Regulation (EU) No 37/2010 with a “No MRL required” classification for rabbits. Furthermore, and with reference to Article 5 of Regulation (EC) No 479/2009, the Committee agreed to extrapolate the recommendation for rabbits to all food producing species.
More information about the above recommendation will be published on the Agency's website.
The Committee adopted two separate scientific advice reports further to a request for:
- Initial advice on efficacy issues for an antimicrobial product for pigs; and
- Follow up advice on quality, safety and efficacy issues for a diagnostic product for pigs.
Minor use, minor species (MUMS)/limited market
Following the Committee's review of the request for classification under the MUMS/limited market policy, the CVMP classified an immunological product in sheep as indicated for MUMS/limited market and eligible for reduced data requirements. No financial incentives will apply as authorised products already exist in the EU for the indications.
The Committee reviewed the PSURs for Aivlosin, Broadline, BTVPUR AlSap 2-4, Contacera, Draxxin, Equip WNV, Improvac, NexGard, Oncept IL-2, Panacur AquaSol, Parvoduk, Porcilis ColiClos, Porcilis PCV M Hyo, Purevax FeLV, Suvaxyn Circo+Mh RTU, Vectra Felis, Versican Plus DHPPi/L4, Versican Plus DHPPi/L4R and Zycortal, and concluded that no further action or changes to their product information were required. In addition, with regard to NexGard the Committee requested a targeted PSUR on all neurological adverse events.
Concept papers, guidelines and SOPs
The Committee adopted a reflection paper on anthelmintic resistance (EMA/CVMP/EWP/573536/2013) following the close of a second public consultation. The reflection paper addresses the current views on issues in relation to anthelmintic resistance. The comments received during the consultation procedure and at a focus group meeting have been taken into account for the revision of the reflection paper.
The Committee adopted a draft revised guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.3) for a 6-month period of public consultation. The current guideline has been revised to align CVMP requirements with the new VICH GL52 on Bioequivalence: blood level bioequivalence study, and specifies requirements for the design, conduct, and evaluation of bioequivalence studies for pharmaceutical forms with systemic action. In addition, guidance is given on how in vitro data in specific cases may be used to allow bridging of safety and efficacy data.
The document above will be published on the Agency's website.
The Committee adopted a revised guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/IWP/123243/2006-Rev.3) following the close of the public consultation. The revised guideline describes the data requirements regarding immunological veterinary medicinal products classified as MUMS/limited market.
The Committee adopted updated questions and answers on the following pharmacovigilance topic:
- Serious non-fatal adverse events and reporting rules
The questions and answers document will be published on the Agency's website.
- Activyl Tick Plus: EPAR
- Aivlosin: EPAR
- Broadline: EPAR
- BTVPUR AlSap 2-4: EPAR
- Cardalis: EPAR
- Contacera: EPAR
- Draxxin: EPAR
- Equip WNV (previously Duvaxyn WNV): EPAR
- Improvac: EPAR
- NexGard: EPAR
- Oncept IL-2: EPAR
- Panacur AquaSol: EPAR
- Parvoduk: EPAR
- Porcilis ColiClos: EPAR
- Porcilis PCV M Hyo: EPAR
- Prevomax: EPAR
- Purevax FeLV: EPAR
- Suvaxyn Circo+MH RTU: EPAR
- Vectra Felis: EPAR
- Versican Plus DHPPi/L4: EPAR
- Versican Plus DHPPi/L4R: EPAR
- Zulvac 1 Bovis: EPAR
- Zulvac 1 Ovis: EPAR
- Zulvac 1+8 Bovis: EPAR
- Zulvac 1+8 Ovis: EPAR
- Zulvac 8 Bovis: EPAR
- Zulvac 8 Ovis: EPAR
- Zulvac SBV: EPAR
- Zycortal: EPAR