EMEA-003421-PIP01-23 - paediatric investigation plan
Olutasidenib
PIPHuman
Key facts
- Active Substance
- Olutasidenib
- Therapeutic area
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Decision number
- P/0536/2023
- PIP number
- EMEA-003421-PIP01-23
- Pharmaceutical form(s)
- Capsule, hard
- Condition(s) / indication(s)
- Treatment of acute myeloid leukaemia
- Route(s) of administration
- Oral use
- Contact for public enquiries
Rigel Pharmaceuticals B.V.
E-mail: asiddiqui@rigel.com
Tel. +1 6506241162- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date