EMEA-002691-PIP02-20 - paediatric investigation plan

Brolucizumab

Key facts

• Invented name:
  Beovu
• Active substance:
  Brolucizumab
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0408/2020
• PIP number:
  EMEA-002691-PIP02-20
• Pharmaceutical form(s):
  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:
  23/10/2020
• Compliance check done:
  No

Decision

P/0408/2020 : EMA decision of 23 October 2020 on the granting of a product specific waiver for brolucizumab (Beovu), (EMEA-002691-PIP02-20)

Adopted Reference Number: EMA/539297/2020