This medicine is authorised for use in the European Union.


Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. It should be used in combination with safer sex practices, such as using condoms.

Apretude contains the active substance cabotegravir.

This EPAR was last updated on 20/09/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
ViiV Healthcare B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Van Asch van Wijckstraat 55 H
3811 LP Amersfoort
The Netherlands

Product information

Apretude - EMEA/H/C/005756 -

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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

Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1).

Assessment history

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