SIRTURO

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

Active ingredients

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

1	Bedaquiline UNII P04QX2C1A5 - BEDAQUILINE FUMARATE
	Bedaquiline is a diarylquinoline. Bedaquiline specifically inhibits mycobacterial ATP (adenosine 5'-triphosphate) synthase, an essential enzyme for the generation of energy in Mycobacterium tuberculosis. The inhibition of ATP synthase leads to bactericidal effects for both replicating and non-replicating tubercle bacilli.
	Read more about Bedaquiline

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
SIRTURO 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
J04AK05		J Antiinfectives for systemic use → J04 Antimycobacterials → J04A Drugs for treatment of tuberculosis → J04AK Other drugs for treatment of tuberculosis
Discover more medicines within J04AK05

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
EE	Ravimiamet	1642496, 1708589, 1845402
ES	Centro de información online de medicamentos de la AEMPS	113901002
FI	Lääkealan turvallisuus- ja kehittämiskeskus	518777
FR	Base de données publique des médicaments	65690588
GB	Medicines & Healthcare Products Regulatory Agency	379783
HK	Department of Health Drug Office	64766
IL	מִשְׂרַד הַבְּרִיאוּת	8461
IT	Agenzia del Farmaco	043332016, 043332028, 043332030
JP	医薬品医療機器総合機構	6222007F1023
LT	Valstybinė vaistų kontrolės tarnyba	1072967, 1082210, 1092351
NZ	Medicines and Medical Devices Safety Authority	17632
PL	Rejestru Produktów Leczniczych	100322640, 100463295
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W60621001, W60621002
TR	İlaç ve Tıbbi Cihaz Kurumu	8699593015311
US	FDA, National Drug Code	59676-701, 59676-702
ZA	Health Products Regulatory Authority	47/20.2.3/1182