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.
This EPAR was last updated on 29/03/2021
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 |
66
|
Date of issue of marketing authorisation valid throughout the European Union |
25/08/1996
|
Contact address |
Knollstrasse
67061 Ludwigshafen Germany |
Product information
03/03/2021 Norvir - EMEA/H/C/000127 - N/0160
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Antivirals for systemic use
Therapeutic indication
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).