Proteq West Nile
Opinion
On 20 April 2023, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1 , recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Proteq West Nile. The marketing authorisation holder for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.
Proteq West Nile is currently authorised as suspension for injection. The variation concerns the alignment of the product information with version 9.0 of the QRD template and to update the product information to implement the outcome of signal detection activities: - addition of 'injection site abscess' with a very rare frequency in section 3.6 Adverse events.
Detailed conditions for the use of this product are described in the updated summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
1 Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.
Key facts
| Name |
Proteq West Nile |
| Agency product number |
EMEA/V/C/002005 |
| International non-proprietary name (INN) or common name |
|
| Species |
Horses
|
| Active substance |
|
| Date opinion adopted |
20/04/2023 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |