MHRA-100279-PIP01-21

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide
Invented Name
Not yet available
PIP Number MHRA-100279-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for solution for infusion
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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide.pdf
Published Date 04/05/2022