Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-18 March 2021
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CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for a type II variation application for Cortavance (hydrocortisone aceponate)to add “for alleviation of clinical signs associated with atopic dermatitis in dogs” as a new therapeutic indication.
The Committee adopted by consensus positive opinions for type II grouped variation applications concerning quality-related changes for:
- Ingelvac CircoFlex and Ingelvac MycoFlex (worksharing procedure)
- MS-H Vaccine
The Committee adopted by consensus a positive opinion for a type IB variation application (subject to a worksharing procedure) concerning quality-related changes for Suvaxyn Circo+MH RTU and Suvaxyn Circo.
Withdrawal of applications
The Committee was informed of the formal notification from ECO Animal Health Europe Limited of their decision to withdraw the extension application for a new target species (chickens) for Aivlosin.More information about this extension application and the state of the scientific assessment at the time of the withdrawal will be made available in a public assessment report. The report, together with the withdrawal letter from the applicant will be published on the Agency’s website in due course.
Maximum residue limits
The Committee adopted by majority a positive opinion recommending the extension of maximum residue limits for bambermycin to chickens.
Scientific advice
The Committee adopted four separate scientific advice reports further to requests for initial advice of which two concerned immunological and two pharmaceutical products. The respective target species were dogs, horses, cattle and pigs. The Committee also adopted a clarification report on scientific advice for a pharmaceutical product for dogs.
Minor use, minor species (MUMS)/limited market
Following the Committee’s review of a requests for classification under the MUMS/limited market policy, the CVMP classified a product (ATCvet classification: antiparasitic products, insecticides and repellents) for gilthead seabream (Sparus aurata) as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is eligible for financial incentives as it is intended for use in food producing species.
Pharmacovigilance
The Committee reviewed the PSUR for Comfortis and concluded that changes to its product information were required. The Committee reviewed also the PSURs for Arti-Cell Forte, Aservo EquiHaler, Clevor, Forceris and Imrestor,and concluded that no further action or changes to their product information were required.
Working parties
The Committee reviewed and adopted the mandate, objectives and rules of procedure for the CVMP Novel Therapies and Technologies Working Party (NTWP).
Organisational matters
The CVMP was informed of the Programme - European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021 for the EMA/AnimalhealthEurope Info Day to be held on
25 March 2021. The focus of this Info Day will be on the implementation of Regulation (EU) 2019/6.
More information about the above-mentioned medicines, including their full indications, guidelines, reflection papers, questions and answers and other documents, such as overviews on comments received during consultation, can be found below in “Related content”.