MHRA-101170-PIP01-23

Key Facts

Active Substance
Active Substance:
  • IRINOTECAN HYDROCHLORIDE TRIHYDRATE
Invented Name
  • ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion
  • ONIVYDE pegylated liposomal
PIP Number MHRA-101170-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • All pharmaceutical forms
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of pancreatic cancer
Route(s) of administration
Route(s) of administration:
  • All routes of administration
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):IRINOTECAN HYDROCHLORIDE TRIHYDRATE.pdf
Published Date 03/10/2024