MHRA-100186-PIP01-21

Key Facts

Active Substance
Active Substance:
  • depemokimab
Invented Name
Depemokimab
PIP Number MHRA-100186-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Treatment of chronic rhinosinusitus with nasal polyps (CRSwNP)
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
  • GlaxoSmithKline UK Limited
  • Country United Kingdom
  • Tel 02080475000
  • Email oax52639@gsk.com
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):depemokimab.pdf
Published Date 25/05/2023