Rezolsta
darunavir / cobicistat
Table of contents
Overview
Rezolsta is a medicine usedfor treating patients human immunodeficiency virus type 1 (HIV-1), a virus 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 |
15
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Date of issue of marketing authorisation valid throughout the European Union |
19/11/2014
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Contact address |
Turnhoutseweg 30 |
Product information
10/11/2022 Rezolsta - EMEA/H/C/002819 - WS2342/G
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
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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.