Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-5729/1 |
Trade Name | Dose Form | Strength | Identifier |
3TC | Oral solution | 10 mg/mL | |
Sponsor | Application date | Registration situation | Classification |
GlaxoSmithKline NZ Limited Private Bag 106600 Downtown AUCKLAND 1143 | 4/8/1995 | Consent given Approval date: 11/6/1998 | Prescription |
Composition
Component | Ingredient | Manufacturer |
oral solution | Active | |
Lamivudine 10 mg/mL | 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 | ||
Banana flavour 59.256 AP0551 | ||
Citric acid | ||
Methyl hydroxybenzoate | ||
Propyl hydroxybenzoate | ||
Propylene glycol | ||
Purified water | ||
Sodium citrate dihydrate | ||
Strawberry flavour 057883 AP0551 | ||
Sucrose |
Production
Manufacturing step | Manufacturer |
Manufacture of Final Dose Form | Bora Pharmaceutical Services Inc 7333 Mississauga Road North Mississauga, Ontario L5N 6L4 CANADA |
Packing | Bora Pharmaceutical Services Inc 7333 Mississauga Road North Mississauga, Ontario L5N 6L4 CANADA |
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, | 240 mL | 18 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 |
25/11/2022 | Changed Medicine Notification | Contraindications, warnings and precautions; Administrative fee (CMN) | Granted 15/2/2023 | 9/12/2022 |