MHRA-101170-PIP01-23

Key Facts

PIPS 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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):IRINOTECAN HYDROCHLORIDE TRIHYDRATE.pdf
Published Date 03/10/2024