MHRA-100505-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • copanlisib dihydrochloride
Invented Name
  • Aliqopa
  • Aliqopa
  • Aliqopa
  • Aliqopa
  • Aliqopa
PIP Number MHRA-100505-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Treatment of mature B-cell neoplasms
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
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):copanlisib dihydrochloride.pdf
Published Date 25/05/2023