EMEA-001992-PIP02-16-M01 - paediatric investigation plan

lenadogene nolparvovec

Key facts

• Active substance:
  lenadogene nolparvovec
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0327/2020
• PIP number:
  EMEA-001992-PIP02-16-M01
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of Leber Hereditary Optic Neuropathy
• Route(s) of administration:
  Intravitreal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/08/2020
• Compliance check done:
  No

Decision

P/0327/2020: EMA decision of 14 August 2020 on the acceptance of a modification of an agreed paediatric investigation plan for lenadogene nolparvovec (GS010) (EMEA-001992-PIP02-16-M01)

Adopted Reference Number: EMA/420429/2020