EMEA-002936-PIP01-20 - paediatric investigation plan

Anti-alpha-synuclein human monoclonal antibody

Key facts

• Active Substance:
  Anti-alpha-synuclein human monoclonal antibody
• Therapeutic area:
  Neurology
• Decision number:
  P/0136/2021
• PIP number:
  EMEA-002936-PIP01-20
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  • Treatment of multiple system atrophy
  • Treatment of Parkinson's disease
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/04/2021

Decision

P/0136/2021 : EMA decision of 16 April 2021 on the granting of a product specific waiver for anti-(alpha-synuclein) human monoclonal antibody, (EMEA-002936-PIP01-20)

Reference Number: EMA/152093/2021