PIFELTRO

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

Active ingredients

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

1	Doravirine UNII 913P6LK81M - DORAVIRINE
	Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Doravirine does not inhibit the human cellular DNA polymerases α, β, and mitochondrial DNA polymerase γ.
	Read more about Doravirine

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
PIFELTRO 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
J05AG06		J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AG Non-nucleoside reverse transcriptase inhibitors
Discover more medicines within J05AG06

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
CA	Health Products and Food Branch	02481545
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	5522-MEE-1020
EE	Ravimiamet	1783155, 1783166
ES	Centro de información online de medicamentos de la AEMPS	1181332001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	537089
FR	Base de données publique des médicaments	68914027
GB	Medicines & Healthcare Products Regulatory Agency	368789
HK	Department of Health Drug Office	66558
IL	מִשְׂרַד הַבְּרִיאוּת	8524
IT	Agenzia del Farmaco	047421019, 047421021
JP	医薬品医療機器総合機構	6250049F1021
LT	Valstybinė vaistų kontrolės tarnyba	1086748, 1086749
NL	Z-Index G-Standaard, PRK	198676
PL	Rejestru Produktów Leczniczych	100416536
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65374001, W65374002
TR	İlaç ve Tıbbi Cihaz Kurumu	8699636091548
US	FDA, National Drug Code	0006-3069
ZA	Health Products Regulatory Authority	53/20.2.8/0232