Entecavir Viatris (previously Entecavir Mylan)

March 10, 2025

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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.

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.

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.

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.

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.

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.

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.

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.

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.

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First published: 10/10/2017Last updated: 26/10/2017

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English (EN)
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First published: 29/07/2022

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Product information

English (EN)
(281.17 KB – PDF)

First published: 10/10/2017Last updated: 10/03/2025

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Latest procedure affecting product information:
N/0000254071

06/03/2025

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).

English (EN)
(7.9 KB – PDF)

First published: 10/10/2017Last updated: 16/01/2024

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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.

More information on Entecavir Mylan

English (EN)
(66.45 KB – PDF)

First published: 09/07/2007Last updated: 07/12/2012

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Overview

What is Entecavir Mylan and what is it used for?

How is Entecavir Mylan used?

How does Entecavir Mylan work?

How has Entecavir Mylan been studied?

What are the benefits and risks of Entecavir Mylan?

Why is Entecavir Mylan approved?

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

Other information about Entecavir Mylan

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

More information on Entecavir Mylan

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