EMEA-002137-PIP01-17 - paediatric investigation plan

recombinant humanized anti-alpha-synuclein IgG1 monoclonal antibody

Key facts

• Active substance:
  recombinant humanized anti-alpha-synuclein IgG1 monoclonal antibody
• Therapeutic area:
  Neurology
• Decision number:
  P/0236/2017
• PIP number:
  EMEA-002137-PIP01-17
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  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:
  09/08/2017
• Compliance check done:
  No

Decision

P/0236/2017: EMA decision of 9 August 2017 on the granting of a product specific waiver for recombinant humanized anti-alpha-synuclein IgG1 monoclonal antibody (EMEA-002137-PIP01-17)

Adopted Reference Number: EMA/434819/2017