Rekambys
rilpivirine
Table of contents
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.
-
List item
Rekambys : EPAR - Medicine overview (PDF/136.55 KB)
First published: 04/01/2021
EMA/565630/2020 -
-
List item
Rekambys : EPAR - Risk-management-plan summary (PDF/108.6 KB)
First published: 04/01/2021
Last updated: 03/11/2021
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 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 NV
|
Revision |
7
|
Date of issue of marketing authorisation valid throughout the European Union |
17/12/2020
|
Contact address |
Turnhoutseweg 30 |
Product information
21/11/2022 Rekambys - EMEA/H/C/005060 - IB/0014
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
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.