EMEA-002691-PIP01-19 - paediatric investigation plan

Brolucizumab

Key facts

• Active substance:
  Brolucizumab
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0112/2020
• PIP number:
  EMEA-002691-PIP01-19
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of visual impairment due to macular edema associated with retinal vein occlusion (branch RVO or central RVO)
• Route(s) of administration:
  Intravitreal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  20/03/2020
• Compliance check done:
  No

Decision

P/0112/2020: EMA decision of 20 March 2020 on the granting of a product specific waiver for brolucizumab (EMEA-002691-PIP01-19)

Adopted Reference Number: EMA/100929/2020