Melovem
Opinion
On 19-20 April 2023, 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 Melovem. The marketing authorisation holder for this veterinary medicinal product is Dopharma Research B.V.
Melovem is currently authorised as a solution for injection for cattle and horses. The variation is to add a new strength and pharmaceutical form - a 15 mg/ml oral suspension for 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 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.
Key facts
| Name |
Melovem |
| Agency product number |
EMEA/V/C/000152 |
| International non-proprietary name (INN) or common name |
|
| Species |
Pigs
Calves
|
| 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 |
20/04/2023 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |