SIRTURO

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

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 about Bedaquiline

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SIRTURO Tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

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