Source: Health Products and Food Branch (CA) Revision Year: 2022
3TC – Antiretroviral agent.
Lamivudine tablets, 150 mg, oral.
Lamivudine tablets, 300 mg, oral.
Lamivudine oral solution, 10 mg/mL.
Table 4. Dosage Forms, Strengths, Composition and Packaging:
| Route of Administration | Dosage Form / Strength/Composition | Non-medicinal Ingredients |
|---|---|---|
| Oral | Tablets/150 mg | hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide |
| Tablets/300 mg | black iron oxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide | |
| Oral Solution/10 mg/mL | artificial strawberry and banana flavours, citric acid (anhydrous), hydrochloric acid, methylparaben, propylparaben, propylene glycol, sodium citrate (dihydrate), sodium hydroxide, sucrose and water. Each 150 mg (15 mL) contains 3 g of sucrose |
3TC tablets 150 mg are white, modified diamond-shaped, scored, film-coated tablets and imprinted with “GX CJ7” on both faces. 3TC tablets 300 mg are grey, modified diamond-shaped, film-coated tablets and imprinted with “GX EJ7” on one face.
3TC oral solution is a colourless to pale yellow, strawberry-banana flavour, clear liquid.
150 mg: Supplied in bottles of 60 tablets
300 mg: Supplied in bottles of 30 tablets.
Supplied in 240 mL plastic bottles.
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
ViiV Healthcare ULC, 75 Rue Queen, Suite 1400, Montreal, Quebec, H3C 2N6 249461 |
Date of approval:
December 08, 1995 January 21, 2022 |
| Drug | Countries | |
|---|---|---|
| 3TC | Australia, Canada, Hong Kong, New Zealand |
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