EMEA-002753-PIP01-19 - paediatric investigation plan

Adeno-associated virus serotype 2 encoding human aromatic L-amino acid decarboxylase

Key facts

• Active substance:
  Adeno-associated virus serotype 2 encoding human aromatic L-amino acid decarboxylase
• Therapeutic area:
  Neurology
• Decision number:
  P/0205/2020
• PIP number:
  EMEA-002753-PIP01-19
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of Parkinson's disease
• Route(s) of administration:
  Intracerebral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/06/2020
• Compliance check done:
  No

Decision

P/0205/2020: EMA decision of 16 June 2020 on the granting of a product specific waiver for adeno-associated virus serotype 2 (AAV2) encoding human aromatic L-amino acid decarboxylase (hAADC) (EMEA-002753-PIP01-19)

Adopted Reference Number: EMA/288478/2020