VEMLIDY

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

Active ingredients

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

1 Tenofovir alafenamide UNII FWF6Q91TZO - TENOFOVIR ALAFENAMIDE FUMARATE

Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir. Tenofovir alafenamide enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3. Tenofovir alafenamide is primarily hydrolysed to form tenofovir by carboxylesterase 1 in primary hepatocytes. Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination. Tenofovir has activity that is specific to HBV and HIV (HIV-1 and HIV-2). Read about Tenofovir alafenamide

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
VEMLIDY 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
J05AF13		J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AF Nucleoside and nucleotide reverse transcriptase inhibitors
Discover more medicines within J05AF13

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 546820020000407
Country: CA	Health Products and Food Branch	Identifier(s): 02464241
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 12596653, 12596682
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 5550-MEE-1020
Country: EE	Ravimiamet	Identifier(s): 1736513, 1736524
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1161154001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 069912
Country: FR	Base de données publique des médicaments	Identifier(s): 69337678
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 349672
Country: HK	Department of Health Drug Office	Identifier(s): 65249
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8202
Country: IT	Agenzia del Farmaco	Identifier(s): 045253010, 045253022
Country: JP	医薬品医療機器総合機構	Identifier(s): 6250045F1023
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1082008, 1082009
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 143197
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 18957
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100383877
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64759001
Country: SG	Health Sciences Authority	Identifier(s): 15392P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8698760090229, 8698760090236
Country: US	FDA, National Drug Code	Identifier(s): 61958-2301