EMEA-003020-PIP01-21 - paediatric investigation plan

Adeno-associated viral vector serotype rh.10 expressing beta-galactosidase (LYS-GM101)

Key facts

• Active Substance:
  Adeno-associated viral vector serotype rh.10 expressing beta-galactosidase (LYS-GM101)
• Therapeutic area:
  Neurology
• Decision number:
  P/0145/2022
• PIP number:
  EMEA-003020-PIP01-21
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of GM1 gangliosidosis
• Route(s) of administration:
  Intracisternal use
• Contact for public enquiries:

  Lysogene

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  13/05/2022

Decision

P/0145/2022 : EMA decision of 13 May 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for adeno-associated viral vector serotype rh.10 expressing beta-galactosidase (LYS-GM101) (EMEA-003020-PIP01-21)

AdoptedReference Number: EMA/206128/2022