EMEA-002516-PIP02-21 - paediatric investigation plan

Lonafarnib

Key facts

• Active Substance:
  Lonafarnib
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0246/2022
• PIP number:
  EMEA-002516-PIP02-21
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Hepatitis D virus infection
• 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:
  08/07/2022

Decision

P/0246/2022: EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for lonafarnib (EMEA-002516-PIP02-21)

Reference Number: EMA/595664/2022