EMEA-002036-PIP01-16 - paediatric investigation plan

fosmetpantotenate

Key facts

• Active substance:
  fosmetpantotenate
• Therapeutic area:
  Neurology
• Decision number:
  P/0317/2019
• PIP number:
  EMEA-002036-PIP01-16
• Pharmaceutical form(s):
  • Powder for oral suspension
  • Granules for oral suspension
• Condition(s) / indication(s):
  Treatment of Pantothenate Kinase Associated Neurodegeneration
• 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:
  11/09/2020
• Compliance check done:
  No

Decision

P/0317/2019: EMA decision of 11 September 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for fosmetpantotenate (EMEA-002036-PIP01-16)

Adopted Reference Number: EMA/466415/2019