Viramune

RSS

nevirapine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Viramune. 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 Viramune.

For more information about treatment with Viramune, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This EPAR was last updated on 04/12/2018

Authorisation details

Product details
Name
Viramune
Agency product number
EMEA/H/C/000183
Active substance
nevirapine
International non-proprietary name (INN) or common name
nevirapine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AG01
Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
37
Date of issue of marketing authorisation valid throughout the European Union
04/02/1998
Contact address
D-55216 Ingelheim am Rhein
Germany

Product information

29/10/2018 Viramune - EMEA/H/C/000183 - IAIN/0135

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Tablets and oral suspension

Viramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents, and children of any age.

Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.

50- and 100-mg prolonged-release tablets

Viramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adolescents and children three years and above and able to swallow tablets.

Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.

Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.

400-mg prolonged-release tablets

Viramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents and children three years and above and able to swallow tablets.

Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.

Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.

Assessment history

How useful was this page?

Add your rating