EMEA-001095-PIP03-19 - paediatric investigation plan

natalizumab

Key facts

• Invented name:
  Tysabri
• Active substance:
  natalizumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0123/2020
• PIP number:
  EMEA-001095-PIP03-19
• Pharmaceutical form(s):
  Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/03/2020
• Compliance check done:
  Nein

Decision

P/0123/2020: EMA decision of 18 March 2020 on the granting of a product specific waiver for natalizumab (Tysabri), (EMEA-001095-PIP03-19)

Adopted Reference Number: EMA/136524/2020