MHRA-100341-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • ISAVUCONAZONIUM SULFATE
Invented Name
  • Cresemba
  • Cresemba
  • Cresemba
PIP Number MHRA-100341-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Capsules, hard
  • Powder for concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
  • Treatment of invasive aspergillosis
  • Treatment of mucormycosis
Route(s) of administration
  • Oral use
  • Intravenous drip 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):ISAVUCONAZONIUM SULFATE.pdf
Published Date 27/09/2022