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Author: Teva Pharma B.V.


Long information

What is it?

Lamivudine Teva is a medicine that contains the active substance lamivudine. It is available as orange, capsule-shaped tablets (100 mg).
Lamivudine Teva is a ?generic medicine?. This means that Lamivudine Teva is similar to a ?reference medicine? already authorised in the European Union (EU) called Zeffix. For more information on generic medicines, see the question-and-answer document here.

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Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Lamivudine Teva is used to treat adult patients who have chronic (long term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus). It is used in patients with:

  • compensated liver disease (when the liver is damaged but functions normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised levels of the liver enzyme ?alanine aminotransferase? [ALT] and signs of damage when liver tissue is examined under a microscope);
  • decompensated liver disease (when the liver is damaged and does not function normally). The medicine can only be obtained with a prescription.

How is it used?

Treatment with Lamivudine Teva should be initiated by a doctor who has experience in the management of chronic hepatitis B. The recommended dose of Lamivudine Teva is 100 mg once a day. Lamivudine Teva can be taken with or without food. The dose needs to be lowered for patients who have problems with their kidneys. The duration of treatment depends on the patient?s condition and response to treatment. For more information, please see the Summary of Product Characteristics (also part of the EPAR).

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How does it work?

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

How has it been studied?

Because Lamivudine Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Zeffix. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What benefits has it shown during the studies?

Because Lamivudine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.

What is the risk associated?

Because Lamivudine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Lamivudine Teva has been shown to have comparable quality and to be bioequivalent to Zeffix. Therefore, the CHMP?s view was that, as for Zeffix, the benefit outweighs the identified risk. The Committee recommended that Lamivudine Teva be given marketing authorisation.

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