EMEA-001662-PIP01-14-M05 - paediatric investigation plan

Palovarotene

Key facts

• Active substance:
  Palovarotene
• Therapeutic area:
  Other
• Decision number:
  P/0562/2021
• PIP number:
  EMEA-001662-PIP01-14-M05
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of fibrodysplasia ossificans progressiva
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/12/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001662-PIP01-14-M05
• Compliance opinion date:
  10/11/2023
• Compliance outcome:
  Positive

Decision

P/0562/2021 : EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for palovarotene (EMEA-001662-PIP01-14-M05)

Adopted Reference Number: EMA/649951/2021