EMEA-001821-PIP01-15-M08 - paediatric investigation plan
quizartinib
PIPHuman
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Key facts
- Invented name
- Vanflyta
- Active substance
- quizartinib
- Therapeutic area
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Decision number
- P/0203/2024
- PIP number
- EMEA-001821-PIP01-15-M08
- Pharmaceutical form(s)
- Film-coated tablet
- Powder for oral solution
- Condition(s) / indication(s)
- Treatment of acute myeloid leukaemia
- Route(s) of administration
- Oral use
- Contact for public enquiries
Daiichi Sankyo Europe GmbH
Tel. +49 8978080
E-mail: service@daiichi-sankyo.eu- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Όχι