EMEA-002358-PIP02-18-M04 - paediatric investigation plan
avapritinib
PIPHuman
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Key facts
- Invented name
- Ayvakyt
- Active substance
- avapritinib
- Therapeutic area
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Decision number
- P/0363/2024
- PIP number
- EMEA-002358-PIP02-18-M04
- Pharmaceutical form(s)
- Film-coated tablet
- Age appropriate oral solid dosage form
- Condition(s) / indication(s)
- Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
- Route(s) of administration
- Oral use
- Contact for public enquiries
Blueprint Medicines (Netherlands) B.V
E-mail: MedinfoEurope@blueprintmedicines.com
Tel.: +31 850644001- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Не