EMEA-001656-PIP01-14

Key facts

Active substance
Momelotinib
Therapeutic area
Oncology
Decision number
P/0157/2015
PIP number
EMEA-001656-PIP01-14
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral dosage form
Condition(s) / indication(s)
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of essential thrombocythaemia
  • Treatment of polycythaemia vera
  • Treatment of post-essential thrombocythaemia myelofibrosis
  • Treatment of post-polycythaemia vera myelofibrosis
Route(s) of administration
Oral use
Contact for public enquiries
GlaxoSmithKline Trading Services Limited

Tel. +1 438-899-8201
E-mail: eu.paediatric-plans@gsk.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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