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Lamivudine Teva Pharma B.V.

Active Substance: lamivudine
Common Name: lamivudine
ATC Code: J05AF05
Marketing Authorisation Holder: Teva B.V.  
Active Substance: lamivudine
Status: Authorised
Authorisation Date: 2009-12-10
Therapeutic Area: HIV Infections
Pharmacotherapeutic Group: Antivirals for systemic use

Therapeutic Indication

Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.

What is Lamivudine Teva Pharma B.V.?

Lamivudine Teva Pharma B.V. is a medicine containing the active substance lamivudine. It is available as 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.

What is Lamivudine Teva Pharma B.V. 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 Lamivudine Teva Pharma B.V. 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. For more information, see the package leaflet.

How does Lamivudine Teva Pharma B.V. 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 Lamivudine Teva Pharma B.V. been studied?

Because Lamivudine Teva Pharma B.V. is a generic medicine, studies in people 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 are the benefit and risk of Lamivudine Teva Pharma B.V.?

Because Lamivudine Teva Pharma B.V. 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 has Lamivudine Teva Pharma B.V. been approved?

The 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.

Other information about Lamivudine Teva Pharma B.V.

The European Commission granted a marketing authorisation valid throughout the EU for Lamivudine Teva Pharma B.V. on 10 December 2009.

For more information about treatment with Lamivudine Teva Pharma B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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