Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Emtriva 10 mg/mL oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. The clear solution is orange to dark orange in colour. |
Each mL of Emtriva oral solution contains 10 mg of emtricitabine.
Excipient(s) with known effect: Each dose (24 mL) contains 36 mg methyl parahydroxybenzoate (E218), 3.6 mg propyl parahydroxybenzoate (E216), 1.2 mg sunset yellow (E110), 480 mg propylene glycol and has a sodium content of 38 mg.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Emtricitabine |
Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to HIV-1, HIV-2 and HBV. Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase, resulting in DNA chain termination. Emtricitabine is a weak inhibitor of mammalian DNA polymerase α, β and ε and mitochondrial DNA polymerase γ. |
| List of Excipients |
|---|
|
Cotton candy flavouring |
Amber-coloured polyethylene terephthalate (PET) bottle with a child-resistant closure. The pack also contains a 30 mL polypropylene measuring cup with 1.0 mL graduations. The bottle contains 170 mL of solution.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/03/261/003
Date of first authorisation: 24 October 2003
Date of latest renewal: 22 September 2008
| Drug | Countries | |
|---|---|---|
| EMTRIVA | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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