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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 a solution for injection for cattle, pigs and horses. 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 new strength 15 mg/ml and new pharmaceutical form - oral suspension for horses. The indication is:

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.

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.

Key facts

Agency product number
International non-proprietary name (INN) or common name
  • meloxicam
Active substance
  • meloxicam

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.

Date opinion adopted
Company name
Emdoka bvba
Application type

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