XOFLUZA

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

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 more about Baloxavir marboxil

Medication package inserts

Below package inserts are available for further reading:

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