Norvir
ritonavir
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Norvir. 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 Norvir.
Authorisation details
Product details | |
---|---|
Name |
Norvir
|
Agency product number |
EMEA/H/C/000127
|
Active substance |
ritonavir
|
International non-proprietary name (INN) or common name |
ritonavir
|
Therapeutic area (MeSH) |
HIV Infections
|
Anatomical therapeutic chemical (ATC) code |
J05AE03
|
Publication details | |
---|---|
Marketing-authorisation holder |
AbbVie Deutschland GmbH Co. KG
|
Revision |
68
|
Date of issue of marketing authorisation valid throughout the European Union |
25/08/1996
|
Contact address |
Knollstrasse |
Product information
17/10/2022 Norvir - EMEA/H/C/000127 - N/0165
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
Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1-infected patients (adults and children of two years of age and older).