Rekambys

RSS

rilpivirine

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

Overview

Rekambys is used together with another medicine called cabotegravir to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used in adults whose infection is under control with other HIV medicines.

Rekambys contains the active substance rilpivirine.

This EPAR was last updated on 04/01/2021

Authorisation details

Product details
Name
Rekambys
Agency product number
EMEA/H/C/005060
Active substance
rilpivirine
International non-proprietary name (INN) or common name
rilpivirine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AG05
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
Janssen-Cilag International N.V.
Date of issue of marketing authorisation valid throughout the European Union
17/12/2020
Contact address

Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

17/12/2020 Rekambys - EMEA/H/C/005060 -

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Rekambys is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.

Assessment history

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