EMEA-003087-PIP01-21 - paediatric investigation plan

resmetirom

Key facts

• Active Substance:
  resmetirom
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0462/2022
• PIP number:
  EMEA-003087-PIP01-21
• Pharmaceutical form(s):
  Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of non-alcoholic steatohepatitis (NASH)
• 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

P/0462/2022: EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for resmetirom (EMEA-003087-PIP01-21)

AdoptedReference Number: EMA/790574/2022