EMEA-001656-PIP02-19 - paediatric investigation plan

Momelotinib

Key facts

• Active Substance:
  Momelotinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0249/2019
• PIP number:
  EMEA-001656-PIP02-19
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of myelofibrosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/06/2019

Decision

P/0249/2019: EMA decision of 17 June 2019 on the granting of a product specific waiver for momelotinib (EMEA-001656-PIP02-19)

AdoptedReference Number: EMA/364985/2019