Dutrebis

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Withdrawn

This medicine's authorisation has been withdrawn

lamivudine / raltegravir potassium
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

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. 

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. 

The European Public Assessment Report (EPAR) for Dutrebis is updated accordingly to indicate that the marketing authorisation is no longer valid.

Dutrebis : EPAR - Summary for the public

English (EN) (545.33 KB - PDF)

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български (BG) (629.98 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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español (ES) (547.71 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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čeština (CS) (609.64 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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dansk (DA) (546.1 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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Deutsch (DE) (550.11 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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eesti keel (ET) (545.64 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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ελληνικά (EL) (633.99 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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français (FR) (548.69 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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hrvatski (HR) (564.77 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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italiano (IT) (546.79 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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latviešu valoda (LV) (607.81 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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lietuvių kalba (LT) (568.79 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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magyar (HU) (602.36 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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Malti (MT) (609.99 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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Nederlands (NL) (547.49 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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polski (PL) (607.73 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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português (PT) (548.07 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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română (RO) (567.3 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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slovenčina (SK) (607.75 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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slovenščina (SL) (599.84 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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Suomi (FI) (546.51 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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svenska (SV) (546.85 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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Dutrebis : EPAR - Risk-management-plan summary

English (EN) (583.5 KB - PDF)

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Product information

Dutrebis : EPAR - Product Information

English (EN) (1.47 MB - PDF)

First published: Last updated:
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български (BG) (2.46 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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español (ES) (1.59 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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čeština (CS) (2.18 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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dansk (DA) (1.47 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

Deutsch (DE) (1.62 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

eesti keel (ET) (1.52 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

ελληνικά (EL) (2.62 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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français (FR) (1.57 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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hrvatski (HR) (1.52 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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íslenska (IS) (1.51 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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italiano (IT) (1.54 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

latviešu valoda (LV) (2.11 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

lietuvių kalba (LT) (1.55 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

magyar (HU) (2.24 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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Malti (MT) (2.32 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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Nederlands (NL) (1.57 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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norsk (NO) (1.49 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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polski (PL) (2.28 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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português (PT) (1.52 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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română (RO) (1.6 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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slovenčina (SK) (2.09 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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slovenščina (SL) (2.08 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

Suomi (FI) (1.52 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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svenska (SV) (1.53 MB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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Latest procedure affecting product information:-
26/03/2015
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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).

Dutrebis : EPAR - All Authorised presentations

English (EN) (512.62 KB - PDF)

First published: Last updated:
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български (BG) (532.59 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

español (ES) (505.78 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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čeština (CS) (518.13 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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dansk (DA) (513.04 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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Deutsch (DE) (505.36 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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eesti keel (ET) (513.21 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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ελληνικά (EL) (531.89 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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français (FR) (511.19 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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hrvatski (HR) (512.94 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

íslenska (IS) (505.65 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

italiano (IT) (504.82 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

latviešu valoda (LV) (518.64 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

lietuvių kalba (LT) (506.05 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

magyar (HU) (525.39 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

Malti (MT) (526.51 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

Nederlands (NL) (504.99 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

norsk (NO) (505.53 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

polski (PL) (524.61 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

português (PT) (505.92 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

română (RO) (512.93 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

slovenčina (SK) (518.3 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

slovenščina (SL) (516.98 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

Suomi (FI) (504.41 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
View

svenska (SV) (512.18 KB - PDF)

First published: 21/04/2015 Last updated: 27/04/2017
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Product details

Name of medicine
Dutrebis
Active substance
  • lamivudine
  • raltegravir potassium
International non-proprietary name (INN) or common name
  • lamivudine
  • raltegravir potassium
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR16

Pharmacotherapeutic group

  • Antivirals for systemic use
  • Antivirals for treatment of HIV infections, combinations

Therapeutic indication

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).

Authorisation details

EMA product number
EMEA/H/C/003823
Marketing authorisation holder
Merck Sharp Dohme Limited

Hertford Road
EN11 9BU Hoddesdon
United Kingdom

Marketing authorisation issued
26/03/2015
Withdrawal of marketing authorisation
24/04/2017

Assessment history

Dutrebis : EPAR - Public assessment report

Adopted Reference Number: EMA/154027/2015

English (EN) (4.21 MB - PDF)

First published: Last updated:
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CHMP summary of positive opinion for Dutrebis

Adopted Reference Number: EMA/CHMP/38006/2015

English (EN) (538.43 KB - PDF)

First published: Last updated:
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