CRESEMBA

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Spain, UK.

Active ingredients

The drug CRESEMBA contains one active pharmaceutical ingredient (API):

1	Isavuconazole UNII 31Q44514JV - ISAVUCONAZONIUM SULFATE
	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.
	Read more about Isavuconazole

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
CRESEMBA Powder for concentrate for solution for infusion	MPI, EU: SmPC	European Medicines Agency (EU)
CRESEMBA Hard capsule	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
J02AC05		J Antiinfectives for systemic use → J02 Antimycotics for systemic use → J02A Antimycotics for systemic use → J02AC Triazole and tetrazole derivatives
Discover more medicines within J02AC05

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	533220060003507, 533220070003607
CA	Health Products and Food Branch	02483971, 02483998
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	4612-MEE-0319, 4715-MEE-0519
EE	Ravimiamet	1699713, 1699724
ES	Centro de información online de medicamentos de la AEMPS	1151036001, 1151036002
FI	Lääkealan turvallisuus- ja kehittämiskeskus	053809, 141377
FR	Base de données publique des médicaments	60184590, 69181040
GB	Medicines & Healthcare Products Regulatory Agency	310096, 310109
HK	Department of Health Drug Office	66409, 66410
IE	Health Products Regulatory Authority	88899
IL	מִשְׂרַד הַבְּרִיאוּת	8294, 8295
JP	医薬品医療機器総合機構	6179003M1021, 6179404D1029
LT	Valstybinė vaistų kontrolės tarnyba	1078514, 1078515
NL	Z-Index G-Standaard, PRK	134392, 134406
PL	Rejestru Produktów Leczniczych	100075489, 100337179
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65621001, W65622001
SG	Health Sciences Authority	15716P, 15717P
US	FDA, National Drug Code	0469-0420, 0469-0520