Active substance
Isavuconazonium
- SFDA 2
- US FDA 2
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| CRESEMBA 100MG CAPSULE | 100 mg | Capsule, hard · Oral use | 14 Blister | SAR 2925.70 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| CRESEMBA 200MG VIAL | 200 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 1581.40 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
Indications — CHI Daman Drug Formulary
FUNGAL GIT - ASPERGILLOSIS; FUNGAL GIT - MUCORMYCOSIS; PERITONITIS, PERITONEAL DIALYSIS-RELATED PERITONITIS
US FDA United States — FDA approvals (Drugs@FDA)
Safety signals and safety-related labeling changes
- US FDA 8 Dec 2023 CRESEMBA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 8 Dec 2023 CRESEMBA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.