Author: Teva Pharma B.V.


Long information

What is it?

Lamivudine Teva Pharma B.V. is a medicine containing the active substance lamivudine. It is available as grey, diamond-shaped tablets (150 and 300 mg).
Lamivudine Teva Pharma B.V. is a ?generic medicine?. This means that Lamivudine Teva Pharma B.V. is similar to a ?reference medicine? already authorised in the European Union (EU) called Epivir. For more information on generic medicines, see the question-and-answer document here.

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 Pharma B.V. is an antiviral medicine. It is used in combination with other antiviral medicines to treat adults and children infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
The medicine can only be obtained with a prescription.

How is it used?

Treatment with Lamivudine Teva Pharma B.V. should be initiated by a doctor who has experience in the management of HIV infection.
The recommended dose of Lamivudine Teva Pharma B.V. for patients over 12 years of age is 300 mg daily. This can be given either once a day (two 150 mg tablets or one 300 mg tablet) or as one 150 mg tablet twice a day. In children weighing more than 30 kg, the adult dose of 150 mg twice a day should be used. In children weighing between 14 and 30 kg, the dose depends on body weight. Lamivudine Teva Pharma B.V. tablets should ideally be swallowed without crushing. Patients who cannot swallow tablets may crush and add the tablets to a small amount of food or drink, before taking the dose immediately.
The dose of Lamivudine Teva Pharma B.V. needs to be adjusted in patients who have severe problems with their kidneys. Lamivudine Teva Pharma B.V. can be taken with or without food. For more information, see the Package Leaflet.

How does it work?

The active substance in Lamivudine Teva Pharma B.V., lamivudine, is a nucleoside reverse transcriptase inhibitor (NRTI). It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses. Lamivudine Teva Pharma B.V., taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Lamivudine Teva Pharma B.V. does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.

How has it been studied?

Because Lamivudine Teva Pharma B.V. is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Epivir. 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 Pharma B.V. 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 Pharma B.V. 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 Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Epivir. Therefore, the CHMP?s view was that, as for Epivir, the benefit outweighs the identified risk. The Committee recommended that Lamivudine Teva Pharma B.V. be given marketing authorisation.

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