Fintepla
Opinion
On 15 December 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Fintepla. The marketing authorisation holder for this medicinal product is Zogenix ROI Limited.
The CHMP adopted a new indication to add treatment of seizures associated with Lennox-Gastaut syndrome. For information, the full indications will therefore be as follows:1
Fintepla is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1 New text in bold
Key facts
| Name |
Fintepla |
| Agency product number |
EMEA/H/C/003933 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Therapeutic area |
Epilepsies, Myoclonic
|
| Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
| Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
| Date opinion adopted |
15/12/2022 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |