MHRA-101177-PIP01-23

Key Facts

Active Substance
  • Recombinant humanized IgG1, kappa light chain, long-acting monoclonal antibody
  • (navenibart; STAR-0215)
Invented Name
Not available at present
PIP Number MHRA-101177-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of hereditary angioedema
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(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):Recombinant humanized IgG1, kappa light chain, long-acting monoclonal antibody (navenibart STAR-0215).pdf
Published Date 06/01/2025