MHRA-100684-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Clazakizumab
Invented Name
Not available at present
PIP Number MHRA-100684-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
Conditions / Indications:
  • Prevention of cardiovascular events in patients with atherosclerosis
Route(s) of administration
Route(s) of administration:
  • INTRAVENOUS BOLUS
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):Clazakizumab.pdf
Published Date 30/06/2023