Epivir

RSS

lamivudine

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

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 28/10/2021

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
48
Date of issue of marketing authorisation valid throughout the European Union
08/08/1996
Contact address

Van Asch van Wijckstraat 55H
3811 LP Amersfoort
The Netherlands

Product information

16/09/2021 Epivir - EMEA/H/C/000107 - WS1990

Product information documents contain:

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

Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.

Assessment history

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