Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Retrovir 100 mg/10 ml oral solution.
| Pharmaceutical Form |
|---|
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Retrovir 100 mg/10ml oral solution/syrup. A clear, pale yellow, strawberry-flavoured, sugar-free oral solution. The pack contains an oral-dosing syringe which should be fitted to the bottle before use. |
10 ml of solution contains 100 mg zidovudine.
Excipient(s) with known effect:
10 ml of solution contains 6.4 g of maltitol
10 ml of solution contains 20 mg of sodium benzoate
10 ml of solution contains 96 mg of propylene glycol
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Zidovudine |
Zidovudine is an antiviral agent which is highly active in vitro against retroviruses including the Human Immunodeficiency Virus (HIV). |
| List of Excipients |
|---|
|
Maltitol solution E965 |
Retrovir Oral Solution/Syrup: 200 ml amber glass bottle with a plastic or metal cap and polyethylene wad. A 10 ml oral-dosing syringe is included in the pack, with an adaptor, which should be fitted to the bottle before use.
Retrovir Oral Solution/Syrup (Neonate Pack): 200 ml amber glass bottle with a plastic or metal cap and polyethylene wad. A 1 ml oral-dosing syringe is included in the pack, with an adaptor, which should be fitted to the bottle before use.
Not all pack sizes may be marketed.
ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS
PL 35728/0004
Date of first authorisation: 16 August 1991
Date of last renewal: 19 July 2011
| Drug | Countries | |
|---|---|---|
| RETROVIR | Austria, Australia, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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