EMEA-000780-PIP01-09-M04

Key facts

Invented name
Rydapt
Active substance
Midostaurin
Therapeutic area
Oncology
Decision number
P/0027/2018
PIP number
EMEA-000780-PIP01-09-M04
Pharmaceutical form(s)
  • Oral solution
  • Capsule, soft
Condition(s) / indication(s)
  • Treatment of mast cell leukaemia
  • Treatment of malignant mastocytosis
  • Treatment of acute myeloid leukaemia
Route(s) of administration
Oral use
Contact for public enquiries
Novartis Europharm Ltd
Tel. +41 61 324 1111
E-mail: paediatric.enquiries@novartis.com
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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