What is Lamivudine Teva?
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 authorized in the European Union (EU) called Zeffix. For more information on generic medicines, see the questions and answers by clicking here.
What is Lamivudine Teva used for?
Lamivudine Teva is indicated for the treatment of chronic hepatitis B (an infection of the liver that is prolonged and caused by the hepatitis B virus) in adults. It is used in patients with:
- compensated liver disease (the liver is damaged but works regularly), which also shows signs that the virus continues to multiply and shows traces of liver damage (increased levels of the liver enzyme "alanine aminotransferase" [ALT] and signs of damage when the liver tissue is examined under a microscope);
- decompensated liver disease (when the liver is damaged and does not work properly).
The medicine can only be obtained with a prescription.
How is Lamivudine Teva used?
Treatment with Lamivudine Teva should be started by a doctor who has experience in the management of chronic type B hepatitis. The recommended dose of Lamivudine Teva is 100 mg once a day. The medicine can be taken with or without food. In patients with kidney problems it is necessary to reduce the dose. The duration of treatment depends on the patient's condition and the response to therapy. For more information, see the summary of product characteristics (also part of the EPAR).
How does Lamivudine Teva work?
The active substance in Lamivudine Teva, lamivudine, is an antiviral that belongs to the class of nucleoside analogues. Lamivudine interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of virus DNA. Lamivudine stops the production of DNA by the virus, thus preventing it from multiplying and spreading.
What studies have been performed on Lamivudine Teva?
Because Lamivudine Teva is a generic medicine, studies have been limited to tests to show that it is bioequivalent to the reference medicine, Zeffix. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the risks and benefits of Lamivudine Teva?
Because Lamivudine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are assumed to be the same as the latter.
Why has Lamivudine Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Lamivudine Teva has been shown to have comparable quality and to be bioequivalent to Zeffix. It is therefore the opinion of the CHMP that, as in the case of Zeffix, the benefits outweigh the risks identified. The Committee recommended the granting of the marketing authorization for Lamivudine Teva.
More information on Lamivudine Teva:
On 23 October 2009, the European Commission granted a marketing authorization valid throughout the European Union for Lamivudine Teva to Teva Pharma BV.
For the full EPAR of Lamivudine Teva click here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 08-2009.
