MHRA-100493-PIP01-22

Key Facts

Active Substance
Active Substance:
  • BI 765128 - humanized monoclonal antibody of IgG1 subtype targeting NRP1
Invented Name
Not yet available
PIP Number MHRA-100493-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Ophthamology
Conditions / Indications
Conditions / Indications:
  • Diabetic retinopathy
Route(s) of administration
Route(s) of administration:
  • Intravitreal use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BI 765128 - humanized monoclonal antibody of IgG1 subtype targeting NRP1.pdf
Published Date 25/05/2023