<p>On 24 April 2017, the European Commission withdrew the marketing authorisation for Dutrebis (lamivudine / raltegravir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme Limited, which notified the European Commission of its decision to not to market the product in the EU for commercial reasons. </p><p>Dutrebis was granted marketing authorisation in the EU on 26 March 2015 for treatment of human immunodeficiency virus (HIV-1). The marketing authorisation was initially valid for a 5-year period. </p><p>The European Public Assessment Report (EPAR) for Dutrebis is updated accordingly to indicate that the marketing authorisation is no longer valid.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>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).</p></div>
Therapeutic Area (MeSH)
ATC Code
J05AR16
ATC Item
N/A
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| lamivudine | N/A | lamivudine |
| raltegravir potassium | N/A | raltegravir potassium |
EMA Name
Dutrebis
Medicine Name
Dutrebis
Aliases
N/ANo risk management plan link.
