Lamivudine Teva Pharma B.V.

lamivudine

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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 its 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 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.

Name Language First published Last updated
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public BG = bălgarski 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public ES = español 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public CS = čeština 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public DA = dansk 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public DE = Deutsch 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public ET = eesti keel 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public EL = elliniká 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public EN = English 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public FR = français 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public IT = italiano 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public LV = latviešu valoda 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public LT = lietuvių kalba 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public HU = magyar 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public MT = Malti 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public NL = Nederlands 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public PL = polski 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public PT = português 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public RO = română 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public SK = slovenčina 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public SL = slovenščina 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public FI = suomi 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public SV = svenska 16/12/2009 05/01/2016
Lamivudine Teva Pharma B.V. : EPAR - Summary for the public HR = Hrvatski 16/12/2009 05/01/2016

This EPAR was last updated on 12/04/2016 .

Authorisation details

Product details

Product details for Lamivudine Teva Pharma B.V.
NameLamivudine Teva Pharma B.V.
Agency product numberEMEA/H/C/001111
Active substance

lamivudine

International non-proprietary name (INN) or common name

lamivudine

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AF05
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Lamivudine Teva Pharma B.V.
Marketing-authorisation holder

Teva B.V.


 

Revision9
Date of issue of marketing authorisation valid throughout the European Union10/12/2009

Contact address:

Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Product information

Product information

29/03/2016  Lamivudine Teva Pharma B.V. -EMEA/H/C/001111 -IA/0016

Name Language First published Last updated
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016
Lamivudine Teva Pharma B.V. : EPAR - Product Information HR = Hrvatski 16/12/2009 12/04/2016

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.


Name Language First published Last updated
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  
Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations HR = Hrvatski 16/12/2009  

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
Lamivudine Teva Pharma B.V. : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 28/02/2013 12/04/2016

Initial marketing-authorisation documents

Authorised

This medicine is approved for use in the European Union

More information on Lamivudine Teva Pharma B.V.