Human medicines European public assessment report (EPAR): Entecavir Viatris (previously Entecavir Mylan), entecavir, Date of authorisation: 18/09/2017, Revision: 12, Status: Authorised

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

This is a summary of the European public assessment report (EPAR) for Entecavir Viatris (previously Entecavir Mylan). It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Entecavir Viatris.

For practical information about using Entecavir Viatris, patients should read the package leaflet or contact their doctor or pharmacist.

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What is Entecavir Mylan and what is it used for?

Entecavir Mylan is a medicine used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus).

It is used in adults with signs of ongoing liver injury (such as inflammation and fibrosis) when the liver is still working properly (compensated liver disease) and also when the liver is no longer working properly (decompensated liver disease).

It can also be considered for children aged from 2 to 18 years but only in those with compensated liver disease.

Entecavir Mylan contains the active substance entecavir and is a ‘generic medicine’. This means that Entecavir Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Baraclude.

How is Entecavir Mylan used?

Entecavir Mylan can only be obtained with a prescription and is available as tablets (0.5 mg and 1 mg). Treatment with Entecavir Mylan should be started by a doctor with experience in the management of chronic hepatitis B.

Entecavir Mylan is taken once a day. For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Entecavir Mylan (a nucleoside analogue, such as lamivudine). Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose. The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal. The treatment duration is determined by how the patient responds.

The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients.

When treatment is considered appropriate in children, the dose depends on their body weight. Children weighing 32.6 kg and above can be given the 0.5 mg tablets, while an oral solution of entecavir should be used for children weighing less than 32.6 kg. For further information, see the package leaflet.

How does Entecavir Mylan work?

The active substance in Entecavir Mylan, entecavir, is an antiviral belonging to the class of the nucleoside analogues. Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA. Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.

How has Entecavir Mylan been studied?

Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Baraclude, and do not need to be repeated for Entecavir Mylan.

As for every medicine, the company provided studies on the quality of Entecavir Mylan. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Entecavir Mylan?

Because Entecavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Entecavir Mylan approved?

The European Medicines Agency concluded that, in accordance with EU requirements, Entecavir Mylan has been shown to have comparable quality and to be bioequivalent to Baraclude. Therefore, the Agency’s view was that, as for Baraclude, the benefit outweighs the identified risk. The Agency recommended that Entecavir Mylan be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Entecavir Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Entecavir Mylan have been included in the summary of product characteristics and the package leaflet.

Other information about Entecavir Mylan

The European Commission granted a marketing authorisation valid throughout the European Union for Entecavir Mylan on 18 September 2017.

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

Entecavir Mylan : EPAR - Summary for the public

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Entecavir Mylan : EPAR - Risk-management-plan summary

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Product information

Entecavir Viatris : EPAR - Product Information

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Latest procedure affecting product information:

VR/0000325156

05/05/2026

This medicine’s product information is available in all official EU languages. Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Entecavir Viatris (previously Entecavir Mylan) : EPAR - All Authorised presentations

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Product details

Name of medicine

Entecavir Viatris (previously Entecavir Mylan)

Active substance

entecavir monohydrate

International non-proprietary name (INN) or common name

entecavir

Therapeutic area (MeSH)

Hepatitis B

Anatomical therapeutic chemical (ATC) code

J05AF10

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Entecavir Viatris is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:

• compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
• decompensated liver disease.

For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.

Entecavir Viatris is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients.

Authorisation details

EMA product number

EMEA/H/C/004377

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.

Marketing authorisation holder

Viatris Limited

Damastown Industrial Park Dublin 15 Ireland

Opinion adopted

18/05/2017

Marketing authorisation issued

18/09/2017

Revision

12

Assessment history

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Changes since initial authorisation of medicine

Entecavir Viatris : EPAR - Procedural steps taken and scientific information after authorisation

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Entecavir Viatris : EPAR - Procedural steps taken and scientific information after authorisation (archive)

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Initial marketing authorisation documents

Entecavir Mylan : EPAR - Public assessment report

Reference Number:

EMA/555410/2017

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10/10/2017

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10/10/2017

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CHMP summary of positive opinion for Entecavir Mylan

Reference Number:

EMA/CHMP/275743/2017

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21/07/2017

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21/07/2017

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News on Entecavir Viatris (previously Entecavir Mylan)

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017

21/07/2017

More information on Entecavir Mylan

Questions and answers on generic medicines

Reference Number:

EMA/393905/2006 Rev. 2

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Topics

• Generic and hybrid medicines
• Medicines

This page was last updated on

07/05/2026