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.
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List item
Rekambys : EPAR - Medicine overview (PDF/136.55 KB) (new)
First published: 04/01/2021
EMA/565630/2020 -
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List item
Rekambys : EPAR - Risk-management-plan summary (PDF/104.4 KB) (new)
First published: 04/01/2021
Authorisation details
Product details | |
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Name |
Rekambys
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Agency product number |
EMEA/H/C/005060
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Active substance |
rilpivirine
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International non-proprietary name (INN) or common name |
rilpivirine
|
Therapeutic area (MeSH) |
HIV Infections
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Anatomical therapeutic chemical (ATC) code |
J05AG05
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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 |
Janssen-Cilag International N.V.
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Date of issue of marketing authorisation valid throughout the European Union |
17/12/2020
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Contact address |
Product information
17/12/2020 Rekambys - EMEA/H/C/005060 -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.