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EMA Product

Sunlenca

Product approved by European Medicines Agency (EU)

Basic Information

Sunlenca

Regulatory Information

EMEA/H/C/005638

Authorised

August 17, 2022

June 23, 2022

5

October 16, 2024

Company Information

Ireland

Ida Business And Technology Park Carrigtohill Co Cork T45 DP77

GILEAD SCIENCES IRELAND UNLIMITED COMPANY

Drug Classification

Additional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication **Sunlenca injection**, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4.2 and 5.1). **Sunlenca tablet**, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4.2 and 5.1).

Overview Summary

Sunlenca is used, together with other medicines, to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Sunlenca is given when the virus is resistant to other treatments. Sunlenca contains the active substance lenacapavir.

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