Rheumocam - opinion on variation to marketing authorisation

On 13 March 2025, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion¹, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Rheumocam. The marketing authorisation holder for this veterinary medicinal product is Chanelle Pharmaceuticals Manufacturing Ltd.

Rheumocam contains meloxicam as active substance and it is currently authorised in different pharmaceutical forms and strengths, including 5 mg/ml solution for injection for cats. The variation concerns the addition of a new strength, Rheumocam 2 mg/ml solution for injection for cats. Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.

The benefit of Rheumocam 2 mg/ml solution for injection for cats is its alleviation of mild to moderate post-operative pain and inflammation following surgical procedures, e.g. orthopaedic and soft tissue surgery. It is generally well tolerated at the recommended dose.

Rheumocam is a generic of Metacam. Studies have demonstrated the satisfactory quality of Rheumocam, and its bioequivalence to the reference product Metacam is accepted.

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.