EDURANT

This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Canada, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK, United States.

Active ingredients

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

1	Rilpivirine UNII 212WAX8KDD - RILPIVIRINE HYDROCHLORIDE
	Rilpivirine is a diarylpyrimidine NNRTI of HIV-1. Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ.
	Read more about Rilpivirine

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
B4-4149	Tablet	EDURANT 25MG TABLETS TAB 25 mg 30s	57 RNW-PP-134755 EDURANT 25MG TABLETS RILPIVIRINE 25MG RILPIVIRINE 25MG, LACTOSE MONOHYDRATE, CROSCARMELLOSE SODIUM, POVIDONE K30, POLYSORBATE 20, SILICIFIED MICROCRYSTALLINE CELLULOSE, MAGNESIUM STEARATE, HYPROMELLOSE 29106, TITANIUM DIOXIDE, POLYETHYLENE GLYCOL 3000, TRIACETIN B4-4149 Drugs Imported Products 30s Prescription Only Medicine (POM) 12/1/2020 BLOOMS PHARM LTD, 42 ONITIRE STREET, ITIRE, SURULERE, LAGOS 8033374187 bloomspharm@yahoo.com JANSSEN - CILAG SpA, VIa.C. Janssen, Borgo San Michele 04010. Latina. Italy, Italy	07/07/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
EDURANT 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
J05AG05	Rilpivirine	J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AG Non-nucleoside reverse transcriptase inhibitors
Discover more medicines within J05AG05

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	10298B
CA	Health Products and Food Branch	02370603
EE	Ravimiamet	1550720
ES	Centro de información online de medicamentos de la AEMPS	11736001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	189148
FR	Base de données publique des médicaments	63025141
GB	Medicines & Healthcare Products Regulatory Agency	198427
HK	Department of Health Drug Office	61376
IL	מִשְׂרַד הַבְּרִיאוּת	7066
LT	Valstybinė vaistų kontrolės tarnyba	1064181
NG	Registered Drug Product Database	B4-4149
NL	Z-Index G-Standaard, PRK	101559
NZ	Medicines and Medical Devices Safety Authority	15313
PL	Rejestru Produktów Leczniczych	100261312
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W58157001
SG	Health Sciences Authority	14363P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699593095375
US	FDA, National Drug Code	59676-278
ZA	Health Products Regulatory Authority	46/20.2.8/0793