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 States - English - NLM (National Library of Medicine)

janssen products, lp - bedaquiline fumarate (unii: p04qx2c1a5) (bedaquiline - unii:78846i289y) - bedaquiline 100 mg - sirturo is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (mdr-tb). reserve sirturo for use when an effective treatment regimen cannot otherwise be provided. this indication is approved under accelerated approval based on time to sputum culture conversion [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. limitations of use: - do not use sirturo for the treatment of: latent infection due to mycobacterium tuberculosis drug-sensitive tuberculosis extra-pulmonary tuberculosis infections caused by non-tuberculous mycobacteria - latent infection due to mycobacterium tuberculosis - drug-sensitive tuberculosis - extra-pulmonary tuberculosis - infections caused by non-tuberculous myco

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

johnson & johnson sdn. bhd. - bedaquiline fumarate -

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.

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

janssen-cilag ltd - bedaquiline fumarate - tablet - 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.

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

pharma dynamics (pty) ltd - tablet - 100,0 mg - each tablet contains bedaquiline fumarate equivalent to bedaquiline 100,0 mg

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

mylan laboraories limited - tenofovir disoproxil fumarate, lamivudine,efavirenz - tablets film-coated - 300mg+ 300mg+ 400mg

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