Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 May 2023
News
Veterinary
Maximum residue limit
Medicines
CVMP opinions on veterinary medicinal products
Under Regulation (EU) 2019/6
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Eluracat (capromorelin tartrate), from Elanco GmbH, a new product for body weight gain in cats experiencing poor appetite or unintended weight loss resulting from chronic medical conditions.
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
- Chanaxin
- Hiprabovis IBR Marker Live
- Forceris (grouped)
- Librela
- Prevexxion RN, Prevexxion RN+HVT+IBD (worksharing procedure)
- Purevax RCP FeLV, Purevax RCPCh FeLV, Purevax RC, Purevax RCP, Purevax RCPCh (worksharing procedure)
- Reconcile
- Strangvac
- Versican Plus DHPPi/L4R, Versican Plus Pi/L4R (worksharing procedure)
- Ypozane
The Committee adopted by consensus positive opinions for variations requiring assessment to align the product information with version 9.0 of the QRD template for:
- Canigen L4
- MiPet Easecto
- Naxcel
- Nobivac DP Plus - including the update of the product information to implement the outcome of signal detection activities
- Nobivac L4
- Porcilis ColiClos
- Simparica
- Vaxxitek HVT+IBD
Maximum residue limits
Further to a request from the European Commission, the Committee adopted by consensus a revised opinion on the extension of maximum residue limits for ketoprofen to chickens, recommending numerical MRLs. Furthermore, with reference to Article 5 of Regulation (EC) No. 470/2009 and in line with the criteria laid down in Commission Regulation (EU) 2017/880, the Committee agreed to extrapolate the conclusions to poultry.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following one request, the CVMP classified:
- A product (ATCvet classification: Nervous system) for cats and dogs as not intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Pharmacovigilance
The Committee endorsed a recommendation for changes in the product information sections on adverse events for Apoquel as outcome of signal management activities.
Organisational matters
The Committee finalised the preparation of the CVMP/CMDv Informal meeting to be held under the Swedish Presidency of the EU, on 30-31 May 2023. The discussions will focus on:
- Antiparasitic resistance
- Availability of established antibiotics
- Big data, real world evidence and artificial intelligence
- Limited Markets
- Nanomaterials
- Readability of the package leaflet
- Titanium dioxide
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”.