About
This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
- What is Lamivudine Teva Pharma B.V.?
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.
- 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. Lamivudine Teva Pharma B.V. can be taken with or without food. 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 2/2 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 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 benefit and risk are taken as being the same as the reference medicine.
- Why has Lamivudine Teva Pharma B.V. 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.
- 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. to Teva Pharma B.V. on 10 December 2009. The marketing authorisation is valid for five years, after which it can be renewed.
This EPAR was last updated on 16/12/2009 .
More detail is available in the summary of product characteristics
Authorisation details
Product information
Product information
10/12/2009 Lamivudine Teva Pharma B.V. -EMEA/H/C/001111 --
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.
Assessment History
Changes since initial authorisation of medicine
| Name | Language | First published | Last updated |
|---|
Initial marketing-authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Lamivudine Teva Pharma B.V. : EPAR - Public assessment report | (English only) | 16/12/2009 |
Authorised
This medicine is approved for use in the European Union
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