Meloxoral
Opinion
On 6 October 2022, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of an extension to the terms of the marketing authorisation for the veterinary medicinal product Meloxoral. The marketing authorisation holder for this veterinary medicinal product is Dechra Regulatory B.V.
Meloxoral is currently authorised as an oral suspension in two strengths - 0.5mg/ml for use in cats and 1.5mg/ml for use in dogs. It contains meloxicam, a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class (ATCvet code: QM01AC06). The extension concerns the addition of a new pharmaceutical form, chewable tablets, in three new strengths, 1.0mg, 2.5mg and 4.0mg, for use in dogs. The indication is:
Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.
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.
Key facts
| Name |
Meloxoral |
| Agency product number |
EMEA/V/C/000151 |
| International non-proprietary name (INN) or common name |
|
| Species |
Dogs
Cats
|
| Active substance |
|
| Generic |
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 |
06/10/2022 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |