Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 2024
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Strangvac to implement the outcome of the MAH’s signal management process to add adverse reactions in the product information.
- The Committee adopted by consensus a positive opinion for a variation requiring assessment for Strangvac to implement the outcome of the MAH’s signal management process to add adverse reactions in the product information.
- The respective target species were cattle, pigs and sheep (one product), chickens, and squirrel monkeys (one product each).
- Concept papers, guidelines
Quality
The Committee adopted an annex to the Guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water on compatibility studies between veterinary medicinal products and biocidal products (EMA/CVMP/QWP/592906/2022) following close of public consultation. - The comments received during the consultation procedure were taken into account for the revision of the annex.