CVMP viewpoints on veterinary medicinal products
The Council adopted by agreement a positive opinion for an early marketing authorisation application for Sedadex (dexmedetomidine hydrochloride), from Le Vet Beheer B.V., a new generic product used for sedation and analgesia in cats and dogs.
The Council adopted also by agreement a positive opinion for an extension of the existing permission for Metacam (meloxicam), from GmbH Boehringer Vetmedica, concerning the addition of a new route of administration (subcutaneous use) for the 40 mg/ml solution for injection in the target cattle species.
More information concerning the above mentioned medicines, as well as their full indication, will be made known on the Agency’s website.
Renewals of marketing permission
The Council adopted by agreement a positive opinion for the renewal of the marketing permission for Panacur AquaSol. The Council, having re-evaluated the merit-risk balance of the product, concluded that the safety, quality and efficacy continue to be adequately displayed and, therefore, endorsed the renewal of the marketing permission.
Community referrals and associated methods
The Council started a method for Velactis (cabergoline) from Ceva Santé Animale. The issue was notified to the Council by European Commission stipulated under Article 45 of Regulation (EC) Number 726/2004 due to concerns for animal health coming from pharmacovigilance data.
Scientific guidelines
The Council adopted 4 separate scientific guidelines reports further to a appeal for:
• Initial instructions on MRL matters for an antiparasitic veterinary medicinal product for chickens and turkeys;
• Introductory advice on safety and efficacy matters for an anti-inflammatory veterinarymedicinal product for carnivores like dogs;
• Initial guidelines on safety matters for an antiparasitic veterinary medicinal product for cattle(bovine) and sheep(ovine)
• Follow up advice on efficacy matters for a veterinary medicinal product for a respiratory disorder in cattle(bovine).
Minor use, minor species and limited market
Following the Council’s review of one request for categorization under the Minor Use, Minor Species/limited market policy, the CVMP classified:
• Certain indications for an antiparasitic product for utilization in cats(feline) as indicated for Minor Use, Minor Species/limited market and eligible for decreased data demands. The product is not qualified for financial incentives as it is planned for utilization in a non-food producing species.
The Pharmacovigilance
The Council evaluated the post-permission safety study for Trifexis and concluded that no further action or modifications to product literature were required due to the outcome of the study.
The Council evaluated the PSURs for ERYSENG, Melosus, Nobilis Influenza H5N2, Emdocam, Equisolon, ERYSENG PARVO, Innovax ILT, Locatim, NexGard Spectra, Nobivac L4 & Canigen L4, Nobivac Myxo RHD, Versican Plus Pi/L4,ZACTRAN, RevitaCam, Versican Plus DHPPi, Versican Plus L4,ZULVAC 1 Bovis andZULVAC SBV, and concluded that no further action or modifications to their product literature were needed.
The Council also evaluated the PSURs for Cardalis and Broadline and endorsed amendments to their product literature.
The concept papers, guidelines and SOPs
Quality
The Council appropriated Questions and Answers on the following topic:
• Product specific active substance data or information.
The Question and Answer document will be made known on the Agency’s website after its adoption by the CHMP that is foreseen for their June conference next week.
Safety
The Council adopted a draft guideline on user safety of topically given veterinary medicinal products (EMA/CVMP/SWP/721059/2014) for a 6-month period of public discussion. The guideline was developed to provide specific instructions and advice on how user risk assessments should be conducted for such products.This guideline should be utilized in conjunction with the guideline on user protection for pharmaceutical veterinary medicinal products.
Pharmacovigilance
The Council adopted the CVMP combined VeDDRA list of clinical terms for reporting suspected adverse reactions in humans and animals to vet medicinal products (EMA/CVMP/90241/2009-Rev.8) which is utilized for electronic reporting following the yearly review and update. Implementation of the VeDDRA list in Eudra Vigilance Veterinary is planned for October 1st, 2016. The guidance notes on the use of VeDDRA terminology for reporting suspected side reactions in humans and animals (EMA/CVMP/PhVWP/288284/2007-Rev.9) were also adopted, and the call for opinionss on the VeDDRA merit list for EVVet (EMA/123352/2004 - Rev9) as well as the template for submission of proposals (EMA/380688/2010) were also updated.
The above documents will be made known on the Agency’s website.
Novel therapies
The Council agreed for the release of a problem statement prepared by the CVMP Ad hoc Expert Unit on Novel Treatments on stem cells for veterinary use for a 2-month period of public discussion. The problem statement provides the foundation for development of advice on the following topic:
• Stem cell based products for veterinary utilization; specific questions on irrelevant agents.
The discussion is used as a means to facilitate identification of additional appropriate questions relevant to each certain topic. The aim is to take views received into account for developing directions in the form of Questions and Answers.
The statement of the problem will be made known on the Agency’s website.