This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States
The drug CRESEMBA contains one active pharmaceutical ingredient (API):
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1
Isavuconazole
UNII 31Q44514JV - ISAVUCONAZONIUM SULFATE
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Isavuconazole is an active form of isavuconazonium. Isavuconazole inhibits lanosterol 14-alpha demethylase (or CYP51A1) and leads to the accumulation of ergosterol toxic precursors in the fungal cytoplasm. Isavuconazole is indicated for the treatment of invasive aspergillosis and invasive mucormycosis. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| CRESEMBA Hard capsule | European Medicines Agency (EU) | MPI, EU: SmPC | |
| CRESEMBA Powder for concentrate for solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| J02AC05 | J Antiinfectives for systemic use → J02 Antimycotics for systemic use → J02A Antimycotics for systemic use → J02AC Triazole and tetrazole derivatives | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 533220060003507, 533220070003607 |
| Country: CA | Health Products and Food Branch | Identifier(s): 02483971, 02483998 |
| Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 4612-MEE-0319, 4715-MEE-0519 |
| Country: EE | Ravimiamet | Identifier(s): 1699713, 1699724 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 1151036001, 1151036002 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 053809, 141377 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 60184590, 69181040 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 310096, 310109 |
| Country: HK | Department of Health Drug Office | Identifier(s): 66409, 66410 |
| Country: IE | Health Products Regulatory Authority | Identifier(s): 88899 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8294, 8295 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 6179003M1021, 6179404D1029 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1078514, 1078515 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 134392, 134406 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100075489, 100337179 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W65621001, W65622001 |
| Country: SG | Health Sciences Authority | Identifier(s): 15716P, 15717P |
| Country: US | FDA, National Drug Code | Identifier(s): 0469-0420, 0469-0520 |
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