Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-5729 |
| Trade Name | Dose Form | Strength | Identifier |
| 3TC | Film coated tablet | 150 mg | |
| Sponsor | Application date | Registration situation | Classification |
| GlaxoSmithKline NZ Limited Private Bag 106600 Downtown AUCKLAND 1143 | 4/8/1995 | Not available Approval date: 11/6/1998 Notification date: 1/8/2017 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| film coated tablet | Active | |
| Lamivudine 150mg | 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 white YS-1-7706-G | ||
| 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 |
| Glaxo Operations UK Limited t/a Glaxo Wellcome Operations Priory Street Ware Hertfordshire SG12 0DJ UNITED KINGDOM | |
| NZ Site of Product Release | GlaxoSmithKline NZ Limited Level 2 E.2, Generator @GridAKL 12 Madden Street Wynyard Quarter Auckland 1010 |
Packaging
| Package | Contents | Shelf Life |
| Bottle, plastic, HDPE, White | 60 tablets | 60 months from date of manufacture stored at or below 30°C |
Indications
3TC in combination with other anti-retroviral agents is indicated for the treatment of HIV infected adults and children.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 18/3/2024 | Changed Medicine Notification | Finished product manufacture - G1 | Initial evaluation | 3/4/2024 |
