Ryeqo
Opinion
On 14 September 2023, 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 Ryeqo. The marketing authorisation holder for this medicinal product is Gedeon Richter Plc.
The CHMP adopted a new indication for the symptomatic treatment of endometriosis. For information, the full indications for Ryeqo will be as follows1:
Ryeqo is indicated in adult women of reproductive age for:
- treatment of moderate to severe symptoms of uterine fibroids,
- symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.
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.
1New text in bold
Key facts
| Name |
Ryeqo |
| Agency product number |
EMEA/H/C/005267 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Therapeutic area |
Leiomyoma
|
| 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. |
| Date opinion adopted |
14/09/2023 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |