EMEA-002957-PIP02-21 - paediatric investigation plan

Humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide

Key facts

• Active substance:
  Humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0437/2021
• PIP number:
  EMEA-002957-PIP02-21
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of diabetic retinopathy
• Route(s) of administration:
  Intravitreal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2021
• Compliance check done:
  No

Decision

P/0437/2021 : EMA decision of 29 October 2021 on the granting of a product specific waiver for humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide (EMEA-002957-PIP02-21)

Adopted Reference Number: EMA/532591/2021 Corr1