EMEA-001798-PIP02-16

First published: 13/02/2018
Last updated: 13/02/2018
EMA/565652/2017

Active substance	Enasidenib
Therapeutic area	Oncology
Decision number	P/0293/2017
PIP number	EMEA-001798-PIP02-16
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	P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)