Israel - English - Ministry of Health

j-c health care ltd - bedaquiline as fumarate - tablets - bedaquiline as fumarate 100 mg - bedaquiline - sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (mdr-tb) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - bedaquiline fumarate - tablet - 100mg

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - bedaquiline fumarate - tuberculosis, multidrug-resistant - antimycobacterials - sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis (mdr tb) in adults and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. consideration should be given to official guidance on the appropriate use of antibacterial agents.

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

pharmstandard-ufavita ojsc - bedaquiline (bedaquiline fumarate) - tablets - 100mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

pharmstandard-ufavita ojsc - bedaquiline (bedaquiline fumarate) - tablets - 100mg

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - bedaquiline fumarate 120.89mg equivalent to bedaquiline 100 mg;  ;   - tablet - 100 mg - active: bedaquiline fumarate 120.89mg equivalent to bedaquiline 100 mg     excipient: colloidal silicon dioxide croscarmellose sodium hypromellose lactose monohydrate magnesium stearate maize starch microcrystalline cellulose polysorbate 20 - sirturo is indicated in adult (greater than or equal to 18 years) and pediatric patients (12 years to less than 18 years of age and weighing at least 30 kg) as part of combination therapy of pulmonary tuberculosis (tb) due to multi-drug resistant mycobacterium tuberculosis.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

johnson & johnson sdn. bhd. - bedaquiline fumarate -