MHRA-100404-PIP01-21

Key Facts

Active Substance
  • insulin icodec
  • SEMAGLUTIDE
Invented Name
Not yet available
PIP Number MHRA-100404-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection in pre-filled pen
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of type 2 diabetes mellitus
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):insulin icodecSEMAGLUTIDE.pdf
Published Date 07/12/2022