Telzir
fosamprenavir
Table of contents
Overview
Telzir is an antiviral medicine for treating patients aged 6 years or above who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Telzir is used in combination with ritonavir and other HIV medicines. It contains the active substance fosamprenavir.
Authorisation details
Product details | |
---|---|
Name |
Telzir
|
Agency product number |
EMEA/H/C/000534
|
Active substance |
fosamprenavir calcium
|
International non-proprietary name (INN) or common name |
fosamprenavir
|
Therapeutic area (MeSH) |
HIV Infections
|
Anatomical therapeutic chemical (ATC) code |
J05AE07
|
Publication details | |
---|---|
Marketing-authorisation holder |
ViiV Healthcare BV
|
Revision |
48
|
Date of issue of marketing authorisation valid throughout the European Union |
12/07/2004
|
Contact address |
Van Asch van Wijckstraat 55H |
Product information
19/08/2022 Telzir - EMEA/H/C/000534 - IG1531
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
Telzir in combination with low-dose ritonavir is indicated for the treatment of human-immunodeficiency-virus-type-1-infected adults, adolescents and children of six years and above in combination with other antiretroviral medicinal products.
In moderately antiretroviral-experienced adults, Telzir in combination with low-dose ritonavir has not been shown to be as effective as lopinavir / ritonavir. No comparative studies have been undertaken in children or adolescents.
In heavily pretreated patients, the use of Telzir in combination with low-dose ritonavir has not been sufficiently studied.
In protease-inhibitor-experienced patients, the choice of Telzir should be based on individual viral resistance testing and treatment history.
Assessment history
News
-
26/02/2016
-
23/10/2015
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 201523/10/2015