darunavir / cobicistat

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 14/10/2020

Authorisation details

Product details
Agency product number
Active substance
  • darunavir
  • cobicistat
International non-proprietary name (INN) or common name
  • darunavir
  • cobicistat
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Turnhoutseweg 30
2340 Beerse

Product information

03/09/2020 Rezolsta - EMEA/H/C/002819 - WS/1883


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Pharmacotherapeutic group

  • Antivirals for systemic use

  • 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.

Assessment history

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