Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Epivir 10 mg/ml oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear, colourless to pale yellow solution. |
Each ml of oral solution contains 10 mg of lamivudine.
Excipient(s) with known effect:
Each 15 ml dose contains 3 g sucrose (20% w/v).
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Each 15 ml dose contains 300 mg propylene glycol.
Each 15 ml dose contains 39 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lamivudine |
Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Its main mode of action is as a chain terminator of viral reverse transcription. |
| List of Excipients |
|---|
|
Sucrose 20% w/v (3 g/15 ml) |
Cartons containing 240 ml oral solution in a white high density polyethylene (HDPE) bottle, with a child resistant closure. The pack also includes a polyethylene syringe-adapter, and a 10 ml oral dosing syringe comprised of a polypropylene barrel (with ml graduations) and a polyethylene plunger.
The oral dosing syringe is provided for accurate measurement of the prescribed dose of the oral solution. Instructions for use are included in the pack.
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
EU/1/96/015/002
Date of first authorisation: 8 August 1996
Date of last renewal: 28 July 2006
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