Sunlenca

RSS

lenacapavir

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 27/06/2023

Authorisation details

Product details
Name
Sunlenca
Agency product number
EMEA/H/C/005638
Active substance
Lenacapavir sodium
International non-proprietary name (INN) or common name
lenacapavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AX
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Gilead Sciences Ireland Unlimited Company
Revision
01
Date of issue of marketing authorisation valid throughout the European Union
17/08/2022
Contact address

Ida Business And Technology Park
Carrigtohill Co Cork
T45 DP77
Ireland

Product information

23/06/2023 Sunlenca - EMEA/H/C/005638 - IB/0008/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antivirals for systemic use

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).

Assessment history

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