MHRA-100741-PIP01-22

Key Facts

Active Substance
Active Substance:
  • CRISANTASPASE
Invented Name
  • Enrylaze
  • Rylaze
PIP Number MHRA-100741-PIP01-22
Pharmaceutical form(s)
  • Solution for injection
  • Solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of lymphoblastic lymphoma
Route(s) of administration
  • Intramuscular use
  • 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
Yes
Compliance Check Decision Date
Compliance opinion date
25/09/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100741-PIP01-22-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):CRISANTASPASE.pdf
Published Date 19/12/2023