Sunlenca
lenacapavir
Table of contents
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.
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Sunlenca : EPAR - Medicine Overview (PDF/119.54 KB)
First published: 25/08/2022
EMA/624383/2022 -
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Sunlenca : EPAR - Risk management plan summary (PDF/251.35 KB)
First published: 25/08/2022
Authorisation details
Product details | |
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Name |
Sunlenca
|
Agency product number |
EMEA/H/C/005638
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Active substance |
Lenacapavir sodium
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International non-proprietary name (INN) or common name |
lenacapavir
|
Therapeutic area (MeSH) |
HIV Infections
|
Anatomical therapeutic chemical (ATC) code |
J05AX
|
Additional 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 | |
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Marketing-authorisation holder |
Gilead Sciences Ireland Unlimited Company
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Revision |
01
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Date of issue of marketing authorisation valid throughout the European Union |
17/08/2022
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Contact address |
Ida Business And Technology Park |
Product information
23/06/2023 Sunlenca - EMEA/H/C/005638 - IB/0008/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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).