MHRA-100384-PIP01-21

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • datopotamab deruxtecan
Invented Name
Not yet available
PIP Number MHRA-100384-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • All pharmaceutical forms
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of lung cancer
Route(s) of administration
Route(s) of administration:
  • All forms 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):datopotamab deruxtecan.pdf
Published Date 02/11/2022