Key facts

Active Substance
Enasidenib
Therapeutic area
  • Haematology-Hemostaseology
  • Oncology
Decision number
P/0456/2022
PIP number
EMEA-001798-PIP02-16-M01
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
Condition(s) / indication(s)
Treatment of acute myeloid leukaemia
Route(s) of administration
  • Oral use
  • Gastric use
Contact for public enquiries

Bristol-Myers Squibb Pharma EEIG

tel. +44 1423 53 3610
E-mail : medical.information@bms.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0456/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for enasidenib (EMEA- 001798-PIP02-16-M01)

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