EMA/PE/0000232939 - paediatric investigation plan

surabgene lomparvovec

Key facts

• Active substance:
  surabgene lomparvovec
• Therapeutic area:
  Eye disorders
• Decision number:
  EMA/PE/0000232939
• PIP number:
  EMA/PE/0000232939
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of diabetic retinopathy
• Route(s) of administration:
  Suprachoroidal space injection
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/03/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000232939: EMA decision of 19 March 2025 on the granting of a product specific waiver for surabgene lomparvovec

Adopted Reference Number: EMADOC-1700519818-1953684