SPORANOX

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Malta, Mexico, New Zealand, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

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

1	Itraconazole UNII 304NUG5GF4 - ITRACONAZOLE
	Itraconazole is a triazole derivative that inhibits fungal 14α-demethylase, resulting in a depletion of ergosterol and disruption of membrane synthesis by fungi.
	Read more about Itraconazole

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
SPORANOX I.V. Concentrate and solvent for solution for infusion	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

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

ATC Group		Classification
J02AC02	Itraconazole	J Antiinfectives for systemic use → J02 Antimycotics for systemic use → J02A Antimycotics for systemic use → J02AC Triazole and tetrazole derivatives
Discover more medicines within J02AC02

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	8196J
BR	Câmara de Regulação do Mercado de Medicamentos	514504501110312, 514504502117310, 514504503113319, 514504504111311
CA	Health Products and Food Branch	02047454, 02231347
ES	Centro de información online de medicamentos de la AEMPS	59343
FI	Lääkealan turvallisuus- ja kehittämiskeskus	148882, 153494, 155648, 505628, 524330
FR	Base de données publique des médicaments	62469613, 69998156
GB	Medicines & Healthcare Products Regulatory Agency	143878, 200277, 23854, 23859, 23860, 23869, 381678
HK	Department of Health Drug Office	43776, 51056
IE	Health Products Regulatory Authority	61411, 61441, 61455, 61480, 71278
IL	מִשְׂרַד הַבְּרִיאוּת	4187
IT	Agenzia del Farmaco	027808017
MT	Medicines Authority	AA565/03402
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	214M87
NZ	Medicines and Medical Devices Safety Authority	4323
SG	Health Sciences Authority	08206P, 09823P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699593595165
US	FDA, National Drug Code	50458-290, 50458-295
ZA	Health Products Regulatory Authority	30/20.2.2/0429, W/20.2.2/43