Aptivus

RSS

tipranavir

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Aptivus. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aptivus.

This EPAR was last updated on 08/10/2018

Authorisation details

Product details
Name
Aptivus
Agency product number
EMEA/H/C/000631
Active substance
tipranavir
International non-proprietary name (INN) or common name
tipranavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AE09
Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
36
Date of issue of marketing authorisation valid throughout the European Union
25/10/2005
Contact address
Binger Strasse 173
D-55218 Ingelheim am Rhein
Germany

Product information

13/09/2018 Aptivus - EMEA/H/C/000631 - IAIN/0080

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pretreated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors.

Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.

This indication is based on the results of two phase-III studies, performed in highly pretreated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase-II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years.

In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, co-administered with low-dose ritonavir.

Assessment history

Changes since initial authorisation of medicine

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