VEMLIDY

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

Active ingredients

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

1
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 more about Tenofovir alafenamide

Medication package inserts

Below package inserts are available for further reading:

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

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