Rezolsta
darunavir / cobicistat
Table of contents
Overview
that causes acquired immune deficiency syndrome (AIDS). It is given in combination with other HIV medicines for treating adults and adolescents from 12 years of age (and weighing at least 40 kg).
Rezolsta contains the active substances darunavir and cobicistat. The medicine is for use only in patients who have not received HIV treatment before or in previously treated patients whose disease is not expected to be resistant to darunavir and who are healthy enough and have HIV virus levels below a certain threshold.
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List item
Rezolsta : EPAR - Medicine overview (PDF/107.32 KB)
First published: 12/12/2014
Last updated: 24/03/2020
EMA/83065/2020 -
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List item
Rezolsta : EPAR - Risk-management-plan summary (PDF/89.35 KB)
First published: 12/12/2014
Last updated: 24/03/2020
Authorisation details
Product details | |
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Name |
Rezolsta
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Agency product number |
EMEA/H/C/002819
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
HIV Infections
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Anatomical therapeutic chemical (ATC) code |
J05
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Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International N.V.
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Revision |
11
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Date of issue of marketing authorisation valid throughout the European Union |
19/11/2014
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Contact address |
Product information
03/09/2020 Rezolsta - EMEA/H/C/002819 - WS/1883
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
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Pharmacotherapeutic group
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Antivirals for systemic use
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Antivirals for treatment of HIV infections, combinations
Therapeutic indication
Rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years or older.
Genotypic testing should guide the use of Rezolsta.