XOFLUZA

This brand name is authorized in Austria, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, New Zealand, Poland, Romania, Singapore, Turkey, United States, South Africa

Active ingredients

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

1 Baloxavir marboxil UNII 505CXM6OHG - BALOXAVIR MARBOXIL

Baloxavir marboxil is a prodrug that is converted by hydrolysis to baloxavir, the active form that exerts anti-influenza activity. Baloxavir acts on the cap-dependent endonuclease (CEN), an influenza virus-specific enzyme in the polymerase acidic (PA) subunit of the viral RNA polymerase complex and thereby inhibits the transcription of influenza virus genomes resulting in inhibition of influenza virus replication. Read about Baloxavir marboxil

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
XOFLUZA Film-coated tablet	FDA, National Drug Code (US)	MPI, US: SPL/PLR
XOFLUZA Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

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

ATC code	Group title	Classification
J05AX25		J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AX Other antivirals
Discover more medicines within J05AX25

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 5604-MEE-1020, 5616-MEE-1120
Country: EE	Ravimiamet	Identifier(s): 1836480, 1836491, 1882021, 1882043
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 091107, 505339
Country: FR	Base de données publique des médicaments	Identifier(s): 65380237, 65951508, 66832706, 67922971
Country: HK	Department of Health Drug Office	Identifier(s): 66116, 66117
Country: IT	Agenzia del Farmaco	Identifier(s): 049329016, 049329028, 049329030, 049329042, 049329055
Country: JP	医薬品医療機器総合機構	Identifier(s): 6250047F1022, 6250047F2029, 62500B1D1027
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1091736, 1091737
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 21174, 21175
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100446550, 100446566, 100468098
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W67391001, W67392001
Country: SG	Health Sciences Authority	Identifier(s): 15679P, 15680P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699505091068, 8699505091075, 8699505091105, 8699505091129
Country: US	FDA, National Drug Code	Identifier(s): 50090-4102, 50090-4104, 50242-828, 50242-860
Country: ZA	Health Products Regulatory Authority	Identifier(s): 55/20.2.8/0333, 55/20.2.8/0334