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
Yes
Compliance Check Decision Date
Compliance opinion date
16/10/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100341-PIP01-21-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ISAVUCONAZONIUM SULFATE.pdf
Published Date 01/05/2026