Lamivudine Teva
lamivudine
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Lamivudine Teva. 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 Lamivudine Teva.
Authorisation details
Product details | |
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Name |
Lamivudine Teva
|
Agency product number |
EMEA/H/C/001113
|
Active substance |
lamivudine
|
International non-proprietary name (INN) or common name |
lamivudine
|
Therapeutic area (MeSH) |
Hepatitis B, Chronic
|
Anatomical therapeutic chemical (ATC) code |
J05AF05
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
Teva B.V.
|
Revision |
9
|
Date of issue of marketing authorisation valid throughout the European Union |
23/10/2009
|
Contact address |
Product information
03/06/2020 Lamivudine Teva - EMEA/H/C/001113 - IB/0019
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
Antivirals for systemic use
Therapeutic indication
Lamivudine Teva is indicated for the treatment of chronic hepatitis B in adults with:
- compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1).