MHRA-101410-PIP01-24

Key Facts

Active Substance
Active Substance:
  • ISATUXIMAB
Invented Name
  • Sarclisa
  • Sarclisa
PIP Number MHRA-101410-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
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

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ISATUXIMAB.pdf
Published Date 28/10/2024