Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-9759 |
| Trade Name | Dose Form | Strength | Identifier |
| Sirturo | Tablet | 100 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Janssen-Cilag (New Zealand) Ltd P O Box 62185 Sylvia Park Auckland 1644 | 15/5/2015 | Consent given Approval date: 18/8/2016 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| tablet | Active | |
| Bedaquiline fumarate 120.89mg equivalent to bedaquiline 100 mg | Porton Pharma Solutions Ltd. 1 Fine Chemical Zone Chongqing Chemical Industry Park Changshou Chongqing 401221 CHINA | |
| Janssen Pharmaceutica NV Janssen Pharmaceuticalaan 3 Geel B-2440 BELGIUM | ||
| Dishman Carbogen Amcis Limited Survey No. 47, Paiki Sub, Plot No.1 Ahmedaabad Gujarat 382220 INDIA | ||
| Excipient | ||
| Colloidal silicon dioxide | ||
| Croscarmellose sodium | ||
| Hypromellose | ||
| Lactose monohydrate | ||
| Magnesium stearate | ||
| Maize starch | ||
| Microcrystalline cellulose | ||
| Polysorbate 20 |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Janssen Pharmaceutica NV Plant 1 Turnhoutseweg 30 Beerse B-2340 BELGIUM |
| Johnson & Johnson Private Limited Higi House Opp. Ralliwolf L.B.S Marg, Muland (West), Mumbai Maharashtra 400080 INDIA | |
| Recipharm Pharmaservices Private Limited 34th KM, Tumkur Road Village-Teppada Begur Nelamangala, Bangalore Rural Karnataka Pin: 562 123 INDIA | |
| Manufacture of Final Dose Form | Recipharm Pharmaservices Private Limited 34th KM, Tumkur Road Village-Teppada Begur Nelamangala, Bangalore Rural Karnataka Pin: 562 123 INDIA |
| Packing | Recipharm Pharmaservices Private Limited 34th KM, Tumkur Road Village-Teppada Begur Nelamangala, Bangalore Rural Karnataka Pin: 562 123 INDIA |
| Secondary Packaging | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
| NZ Site of Product Release | Janssen-Cilag (New Zealand) Ltd 507 Mt Wellington Highway AUCKLAND 1060 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, Alu/Alu | 24 tablets | 36 months from date of manufacture stored at or below 30°C protect from light |
| Bottle, HDPE | 188 tablets | 36 months from date of manufacture stored at or below 30°C protect from light |
Indications
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.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 4/9/2023 | Self-Assessable Change Notification | Labelling - G1 (Self assessable) | Notified | 13/9/2023 | |
| 15/5/2015 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 18/8/2016 | 26/5/2015 |
