Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-5729a |
| Trade Name | Dose Form | Strength | Identifier |
| 3TC | Film coated tablet | 300 mg | |
| Sponsor | Application date | Registration situation | Classification |
| GlaxoSmithKline NZ Limited Private Bag 106600 Downtown AUCKLAND 1143 | 22/9/2000 | Not available Approval date: 3/10/2002 Notification date: 20/12/2013 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| film coated tablet | Active | |
| Lamivudine 300mg | Mylan Laboratories Limited Unit 2, Survey No. 10 & 42, Gaddapotharam Kazipally Industrial Area Sangareddy District Telangana 502319 INDIA | |
| Glaxo Wellcome Manufacturing Pte Ltd 1 Pioneer Sector 1 Jurong 628413 SINGAPORE | ||
| Excipient | ||
| Magnesium stearate | ||
| Microcrystalline cellulose | ||
| Opadry grey YS-1-17506A | ||
| Sodium starch glycolate |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Delpharm Poznan S.A. ul. Grunwaldzka 189 Poznan 60-322 POLAND |
| Glaxo Operations UK Limited t/a Glaxo Wellcome Operations Priory Street Ware Hertfordshire SG12 0DJ UNITED KINGDOM | |
| Manufacture of Final Dose Form | Delpharm Poznan S.A. ul. Grunwaldzka 189 Poznan 60-322 POLAND |
| Glaxo Operations UK Limited t/a Glaxo Wellcome Operations Priory Street Ware Hertfordshire SG12 0DJ UNITED KINGDOM | |
| Packing | Delpharm Poznan S.A. ul. Grunwaldzka 189 Poznan 60-322 POLAND |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf Life |
| Bottle, plastic, HDPE, 40 mL, child-resistant closure | 30 tablets | 36 months from date of manufacture stored at or below 30°C |
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 9/1/2023 | Changed Medicine Notification | Change in ownership; Administrative fee (CMN) | Granted 9/3/2023 | 18/1/2023 |
