RUKOBIA

This brand name is authorized in United States. It is also authorized in Austria, Croatia, Estonia, Finland, France, Ireland, Italy, Lithuania, Poland, Romania, Spain.

Active ingredients

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

1	Fostemsavir UNII 2X513P36U0 - FOSTEMSAVIR TROMETHAMINE
	Fostemsavir is a prodrug without significant antiviral activity that is hydrolysed to the active moiety, temsavir, upon cleavage of a phosphonooxymethyl group in vivo. Temsavir binds directly to the gp120 subunit within the HIV-1 envelope glycoprotein gp160 and selectively inhibits the interaction between the virus and cellular CD4 receptor, thereby preventing viral entry into, and infection of, host cells.
	Read more about Fostemsavir

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
RUKOBIA Prolonged-release tablet	MPI, EU: SmPC	European Medicines Agency (EU)
RUKOBIA Extended-release tablet	MPI, US: SPL/PLR	FDA, National Drug Code (US)

Medicine classification

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

ATC Group		Classification
J05AX29		J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AX Other antivirals
Discover more medicines within J05AX29

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
EE	Ravimiamet	1840452
ES	Centro de información online de medicamentos de la AEMPS	1201518001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	036262
FR	Base de données publique des médicaments	69610664
IT	Agenzia del Farmaco	049362015, 049362027
LT	Valstybinė vaistų kontrolės tarnyba	1091816
PL	Rejestru Produktów Leczniczych	100443935
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W68505001, W68505002
US	FDA, National Drug Code	49702-250