Aptivus
tipranavir
Table of contents
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.
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 |
42
|
Date of issue of marketing authorisation valid throughout the European Union |
25/10/2005
|
Contact address |
Binger Strasse 173 |
Product information
28/07/2022 Aptivus - EMEA/H/C/000631 - IAIN/0092
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.