MHRA-100275-PIP01-21

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • SEMAGLUTIDE
Invented Name
  • Ozempic
  • OZEMPIC 0.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
  • Ozempic
  • Ozempic
  • Ozempic
  • Ozempic
  • OZEMPIC 0.25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
  • OZEMPIC 1 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
PIP Number MHRA-100275-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection in pre-filled pen
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of non-alcoholic steatohepatitis (NASH)
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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):SEMAGLUTIDE.pdf
Published Date 17/05/2022