EMEA-001656-PIP01-14 - paediatric investigation plan

Momelotinib

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 formulation
• 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
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/07/2015
• Compliance check done:
  No

Decision

P/0157/2015: EMA decision of 10 July 2015 on the agreement of a paediatric investigation plan and on the granting of a waiver for momelotinib (EMEA-001656-PIP01-14)

Adopted Reference Number: EMA/424132/2015 Summary:

This Decision does not constitute entitlement to the rewards and incentives referred to in Title V of Regulation (EC) No 1901/2006.