Approval of New Products by CVMP
The Committee foe Veterinary Medicinal Products in its recently concluded meeting, adopted by consensus a positive opinion for a marketing authorisation from Axience for Hemosyvet(etamsylate) for prevention and treatment of surgical, post traumatic, obstetric and gynaecological haemorrhages in cattle, sheep, goats, pigs, horses, dogs and cats.
The Committee adopted by consensus a positive opinion for a marketing authorisation from FILAVIE for Cevac REOMUNE for passive immunisation of broilers induced by active immunisation of broiler breeders to reduce clinical signs of tenosynovitis induced by avian reovirus infection.
Variation Approvals for Existing Products
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Syvazul BTV 3 (Bluetongue virus, serotype 3, strain BTV-3/NET2023, inactivated) to add cattle as target species, and to increase of the minimum specification for antigen content in the finished product.
The Committee adopted by consensus a revised positive opinion for a worksharing variation requiring assessment for Nobivac L4, Nobivac LoVo L4 (canine leptospirosis vaccine (inactivated) – addition of a new therapeutic indication or modification of an approved one and addition of associated non-mixed use with Nobivac Rabies. The proposed subsequent update of the name suffix from L4 to L6 (G.I.7.a) was not accepted.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Eluracat to implement the outcome of the MAH’s signal management process to add ‘Anorexia’ and ‘Behavioural disorder’ as rare, and ‘Dyspnoea’, ‘Loss of consciousness, Sedation’, ‘Recumbency’, ‘Muscle weakness’ and ‘Hiding’ as very rare adverse events in the product information.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Divence IBR Marker Live to implement the outcome of the MAH’s signal management process to add new uncommon adverse events in the product information (milk production decrease, reduced food intake and decreased activity). Information on allowing the vaccine to reach room temperature before use was also added to the product information.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Neptra to implement the outcome of the MAH’s signal management process to include ‘Facial paralysis’ as a very rare adverse event in the product information.
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
- Bovela
- Clynav
- Evanovo / Gumbohatch
- Suprelorin
- Tulaven (worksharing procedure with other nationally-authorised products)
- Prevexxion RN/Prevexxion RN+HVT+IBD /Prevexxion RN+HVT /Vaxxitek HVT+IBD
The Committee adopted by consensus positive opinions for variations requiring assessment to align the product information with version 9/9.1 of the QRD template for:
- Prevexxion RN+HVT+IBD
- Recocam
- Zulvac 8 Ovis
Withdrawal of applications
The Committee was informed of the formal notification from Elanco GmbH of their decision to withdraw the application for a variation requiring assessment for Galliprant during the initial phase of the evaluation and before the CVMP could finalise a list of questions to be addressed to the applicant. No CVMP withdrawal assessment report will be produced in line with standard process for a withdrawal at this timepoint.
