Sogroya
Opinion
On 25 May 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 Sogroya. The marketing authorisation holder for this medicinal product is Novo Nordisk A/S.
The CHMP recommended the addition of a new strength of 15 mg/1.5 mL solution for injection in pre-filled pen.
The CHMP adopted an extension to an existing indication as follows1:
Sogroya is indicated for the replacement of endogenous growth hormone (GH) in children aged 3 years and above and adolescents with growth failure due to growth hormone deficiency (paediatric GHD), and in adults with growth hormone deficiency (adult GHD).
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 |
Sogroya |
| Agency product number |
EMEA/H/C/005030 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Therapeutic area |
Growth
|
| 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 |
26/05/2023 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |