EMEA-001095-PIP02-12 - paediatric investigation plan

natalizumab

Key facts

• Invented name:
  • Tysabri
  • Tysabri
• Active substance:
  natalizumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0252/2012
• PIP number:
  EMEA-001095-PIP02-12
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  19/10/2012
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-001095-PIP02-12
• Compliance opinion date:
  16/12/2016
• Compliance outcome:
  Positive

Decision

P/0252/2012: EMA decision of 19 October 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for natalizumab (Tysabri) (EMEA-001095-PIP02-12)

Adopted Reference Number: EMA/659209/2012