MHRA-101844-PIP01-25

Key Facts

Active Substance
Active Substance:
  • SEMAGLUTIDE
Invented Name
  • Ozempic
  • Ozempic
  • Ozempic
  • Ozempic
PIP Number MHRA-101844-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection in pre-filled pen
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
Conditions / Indications:
  • Prevention of peripheral arterial disease
Route(s) of administration
Route(s) of administration:
  • Subcutaneous 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):SEMAGLUTIDE.pdf
Published Date 14/07/2025