MHRA-101404-PIP01-24

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • TRASTUZUMAB DERUXTECAN
Invented Name
  • Enhertu
  • Enhertu
PIP Number MHRA-101404-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of all conditions in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(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):TRASTUZUMAB DERUXTECAN.pdf
Published Date 15/08/2024