On 17 February 2021, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion*, recommending the granting of an extension to the terms of the marketing authorisation for the veterinary medicinal product Emdocam. The marketing authorisation holder for this veterinary medicinal product is Emdoka BVBA.
Emdocam is currently authorised as solution for injection. The active substance of Emdocam is meloxicam, a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class (ATCvet code: QM01AC06). The extension concerns the addition of a 5 mg/ml solution for injection for cattle, pigs and for the new target species dogs and cats. The indications for the new target species, dogs and cats, are:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
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 revised European public assessment report (EPAR) and will be available in all official European Union languages after the extension to the marketing authorisation has been granted by the European Commission.
*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.
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
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Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-17 February 202119/02/2021