MHRA-101404-PIP01-24

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

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):TRASTUZUMAB DERUXTECAN.pdf
Published Date 15/08/2024