Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Sunlenca 300 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Beige, capsule-shaped, film-coated tablets of dimensions 10 mm x 21 mm, debossed with “GSI” on one side of the tablet and “62L” on the other side of the tablet. |
Each film-coated tablet contains lenacapavir sodium equivalent to 300 mg of lenacapavir.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lenacapavir |
Lenacapavir is a multistage, selective inhibitor of HIV-1 capsid function that directly binds to the interface between capsid protein (CA) subunits. Lenacapavir inhibits HIV-1 replication by interfering with multiple, essential steps of the viral lifecycle, including capsid-mediated nuclear uptake of HIV-1 proviral DNA, virus assembly and release, and capsid core formation. |
| List of Excipients |
|---|
|
Tablet core: Mannitol (E421) Film coat: Polyvinyl alcohol (E1203) |
Sunlenca tablets are packaged in child-resistant clear PVC/aluminium/paperboard blister. The blister is packaged with silica gel desiccant in a flexible laminated pouch. Pack size of 5 tablets.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/22/1671/01
| Drug | Countries | |
|---|---|---|
| SUNLENCA | Austria, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Romania, United Kingdom |
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