EMEA-002064-PIP01-16-M06 - paediatric investigation plan
Gilteritinib (as fumarate)
PIPHuman
Estonian is available via eTranslation, the European Commission's machine translation service.
Translate to Estonian | Important information about machine translation
Key facts
- Invented name
- Xospata
- Active substance
- Gilteritinib (as fumarate)
- Therapeutic area
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Decision number
- P/0289/2024
- PIP number
- EMEA-002064-PIP01-16-M06
- Pharmaceutical form(s)
- Film-coated tablet
- Age appropriate oral dosage formulation
- Condition(s) / indication(s)
- Treatment of acute myeloid leukaemia
- Route(s) of administration
- Oral use
- Contact for public enquiries
Astellas Pharma Europe B.V.
E-mail: regulatory.eu@astellas.com
Tel: +31 715454006- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Ei