| EMA number | EMEA/H/C/003823 |
| ATC code | J05AR16 |
| Authorisation | 26 March 2015 |
| Withdrawn | 24 April 2017 |
| Revision | - |
Dutrebis is indicated in combination with other anti?retroviral medicinal products for the treatment of human immunodeficiency virus (HIV?1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections 4.2, 4.4 and 5.1).
LAMIVUDINE AND ZIDOVUDINE — MACLEODS PHARMS LTD, approved 2019-12-13 (ANDA090679).
28,817 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.