VEMLIDY

This brand name is authorized in Nigeria. 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, 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 more about Tenofovir alafenamide

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
B4-9637	Tablet	Vemlidy 25 mg Tablets TAB 25 mg 1 x 30's	Film-coated tablet. Yellow, round, film-coated tablets, 8 mm in diameter, debossed with “GSI” on one side of the tablet and “25” on the other side of the tablet	25/09/2024

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
NG	Registered Drug Product Database	B4-9637
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