Summary of opinion: Metacam, 17/01/2024 Positive
On 16 – 17 January 2024, 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 Metacam. The marketing authorisation holder for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.
Metacam is currently authorised for various therapeutic indications in different target species and is available as several pharmaceutical forms and strengths. The active substance is meloxicam, a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. This grouped variation concerns the modification of the indication for use in cats for Metacam 5 mg/ml solution for injection for dogs and cats and amendments to the product information for Metacam 5 mg/ml solution for injection for dogs and cats, Metacam 2 mg/ml solution for injection for cats, and Metacam 0.5 mg/ml oral suspension for cats and guinea pigs with regard to the follow-up oral treatment after initial injectable administration in cats.
Detailed conditions for the use of this product are described in the 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.
1Applicants 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.
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
