EMEA-003537-PIP01-23 - paediatric investigation plan
human hydroxysteroid-17ß-dehydrogenase type 1 (HSD17B1) enzyme inhibitor
PIPHuman
Key facts
- Active Substance
- human hydroxysteroid-17ß-dehydrogenase type 1 (HSD17B1) enzyme inhibitor
- Therapeutic area
- Reproductive system and breast disorders
- Decision number
- P/0094/2024
- PIP number
- EMEA-003537-PIP01-23
- Pharmaceutical form(s)
- Tablet
- Condition(s) / indication(s)
- Treatment of endometriosis
- Route(s) of administration
- Oral use
- Contact for public enquiries
Organon N.V.
E-mail: regaffairseurope@organon.com
Tel. +358 401585669- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date