Agenerase
amprenavir
Table of contents
Overview
The marketing authorisation for Agenerase has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Agenerase
|
| Agency product number |
EMEA/H/C/000264
|
| Active substance |
amprenavir
|
| International non-proprietary name (INN) or common name |
amprenavir
|
| Therapeutic area (MeSH) |
HIV Infections
|
| Anatomical therapeutic chemical (ATC) code |
J05AE05
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Glaxo Group Ltd.
|
| Revision |
18
|
| Date of issue of marketing authorisation valid throughout the European Union |
20/10/2000
|
| Contact address |
Glaxo Group Limited
Greenford Road Greenford, Middx UB6 0NN United Kingdom |
Product information
29/04/2011 Agenerase - EMEA/H/C/000264 - II/0044
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
Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years. Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5). The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).
The benefit of Agenerase boosted with ritonavir has not been demonstrated in PI nave patients (see section 5.1)