MHRA-100466-PIP01-22

Key Facts

Active Substance
Active Substance:
  • zilovertamab vedotin
Invented Name
not available at present
PIP Number MHRA-100466-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of malignant neoplasms of haematopoietic and lymphoid tissue
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic, and lymphoid tissue)
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):zilovertamab vedotin.pdf
Published Date 30/06/2023