Epivir
lamivudine
Table of contents
Overview
This is a summary of the European Public Assessment Report (EPAR) for Epivir. 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 Epivir.
This EPAR was last updated on 26/06/2020
Authorisation details
Product details | |
---|---|
Name |
Epivir
|
Agency product number |
EMEA/H/C/000107
|
Active substance |
lamivudine
|
International non-proprietary name (INN) or common name |
lamivudine
|
Therapeutic area (MeSH) |
HIV Infections
|
Anatomical therapeutic chemical (ATC) code |
J05AF05
|
Publication details | |
---|---|
Marketing-authorisation holder |
ViiV Healthcare BV
|
Revision |
45
|
Date of issue of marketing authorisation valid throughout the European Union |
08/08/1996
|
Contact address |
Product information
11/06/2020 Epivir - EMEA/H/C/000107 - IG/1237
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
Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.