MHRA-101770-PIP01-24

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • SEMAGLUTIDE
Invented Name
  • Ozempic
  • Ozempic
  • Ozempic
  • Ozempic
  • Ozempic
PIP Number MHRA-101770-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection in pre-filled pen
Therapeutic area
Therapeutic area:
  • Uro-Nephrology
Conditions / Indications
Conditions / Indications:
  • Treatment of Chronic Kidney 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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):SEMAGLUTIDE.pdf
Published Date 02/05/2025