EMEA-001362-PIP01-12-M03 - paediatric investigation plan

cerliponase alfa

Key facts

• Active substance:
  cerliponase alfa
• Therapeutic area:
  Neurology
• Decision number:
  P/0248/2016
• PIP number:
  EMEA-001362-PIP01-12-M03
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Neuronal Ceroid Lipofuscinosis type 2
• Route(s) of administration:
  Intracerebral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/09/2016
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001362-PIP01-12-M03
• Compliance opinion date:
  26/02/2021
• Compliance outcome:
  Positive

Decision

P/0248/2016: EMA decision of 5 September 2016 on the acceptance of a modification of an agreed paediatric investigation plan for cerliponase alfa (EMEA-001362-PIP01-12-M03)

Reference Number: EMA/580078/2016