EMEA-003448-PIP01-23 - paediatric investigation plan

Losmapimod

Key facts

• Active Substance:
  Losmapimod
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0116/2024
• PIP number:
  EMEA-003448-PIP01-23
• Pharmaceutical form(s):
  • Film-coated tablet
  • Dispersible mini-tablet formulation
• Condition(s) / indication(s):
  Treatment of facioscapulohumeral muscular dystrophy
• 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:
  12/04/2024

Decision

P/0116/2024: EMA decision of 12 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for losmapimod (EMEA-003448-PIP01-23)

AdoptedReference Number: EMA/121686/2024