Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-9873 |
| Trade Name | Dose Form | Strength | Identifier |
| Abacavir/Lamivudine Viatris | Film coated tablet | 600 mg/300 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Viatris Limited P O Box 11183 Ellerslie AUCKLAND 1542 | 16/10/2015 | Consent given Approval date: 17/5/2018 Notification date: 12/8/2022 | Prescription |
| Reference product: Kivexa Film coated tablet 600mg/300mg | |||
Composition
| Component | Ingredient | Manufacturer |
| film coated tablet | Active | |
| Abacavir sulfate 702.78mg equivalent to Abacavir 600 mg | Mylan Laboratories Limited Unit 10, Plot 86, Ramky Pharma City (India) Ltd SEZ, JN Pharma City Parawada Mandal, Visakhapatnam District Andhra Pradesh 531019 INDIA | |
| Mylan Laboratories Limited Unit 8, Getula Chodavaram Poosapatirega Mandal Vizianagaram District Andhra Pradesh 535 204 INDIA | ||
| Lamivudine 300mg | Mylan Laboratories Limited Unit 2, Survey No. 10 & 42, Gaddapotharam Kazipally Industrial Area Sangareddy District Telangana 502319 INDIA | |
| Excipient | ||
| Colloidal silicon dioxide | ||
| Crospovidone | ||
| Magnesium stearate | ||
| Microcrystalline cellulose | ||
| Opadry white 13B58894 | ||
| Purified talc | ||
| Silicified microcrystalline cellulose |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Mylan Laboratories Limited Plot No H-12 and H-13 MIDC Waluj, Aurangabad Maharashtra State 431 136 INDIA |
| Manufacture of Final Dose Form | Mylan Laboratories Limited Plot No H-12 and H-13 MIDC Waluj, Aurangabad Maharashtra State 431 136 INDIA |
| Packing | Mylan Laboratories Limited Plot H-12 & H-13 MIDC Waluj Aurangabad Maharashtra State 431 136 INDIA |
| NZ Site of Product Release | Viatris Limited 2B George Bourke Drive Mt. Wellington Auckland 1060 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, PVC/PVdC/Aluminium | 30 dose units | 24 months from date of manufacture stored at or below 25°C |
| Bottle, HDPE | 30 dose units | 24 months from date of manufacture stored at or below 25°C |
Indications
Antiretroviral combination therapy for the treatment of HIV in adults and adolescents from 12 years of age.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 6/9/2023 | Self-Assessable Change Notification | Active ingredient manufacture - G1 (Self assessable) | Notified | 15/9/2023 | |
| 14/8/2023 | Self-Assessable Change Notification | Data sheet - G1 (Self assessable) | Notified | 23/8/2023 | |
| 16/10/2015 | New Intermediate-risk Medicine Application | New intermediate-risk prescription medicine | Granted 17/5/2018 | 23/10/2015 |
