Overview

The marketing authorisation for Lamivudine/Zidovudine Teva has been withdrawn at the request of the marketing-authorisation holder.

Lamivudine/Zidovudine Teva : EPAR - Summary for the public

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Product information

Lamivudine/Zidovudine Teva : EPAR - Product Information

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Suomi (FI) (1.03 MB - PDF)
svenska (SV) (1.04 MB - PDF)

Latest procedure affecting product information: IB/0028

21/03/2022

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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Lamivudine/Zidovudine Teva : EPAR - All Authorised presentations

български (BG) (692.6 KB - PDF)
español (ES) (599.43 KB - PDF)
čeština (CS) (646.79 KB - PDF)
dansk (DA) (601.85 KB - PDF)
Deutsch (DE) (601.75 KB - PDF)
eesti keel (ET) (599.51 KB - PDF)
ελληνικά (EL) (680.34 KB - PDF)
français (FR) (602.47 KB - PDF)
hrvatski (HR) (601.12 KB - PDF)
íslenska (IS) (593.58 KB - PDF)
italiano (IT) (593.2 KB - PDF)
latviešu valoda (LV) (684.71 KB - PDF)
lietuvių kalba (LT) (668.5 KB - PDF)
magyar (HU) (644.2 KB - PDF)
Malti (MT) (674.67 KB - PDF)
Nederlands (NL) (601.51 KB - PDF)
norsk (NO) (600.87 KB - PDF)
polski (PL) (648.5 KB - PDF)
português (PT) (599.51 KB - PDF)
română (RO) (665.61 KB - PDF)
slovenčina (SK) (683.69 KB - PDF)
slovenščina (SL) (614.26 KB - PDF)
Suomi (FI) (593.44 KB - PDF)
svenska (SV) (599.3 KB - PDF)

Product details

Name of medicine
Lamivudine/Zidovudine Teva
Active substance
  • lamivudine
  • zidovudine
International non-proprietary name (INN) or common name
  • lamivudine
  • zidovudine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR01

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.

Authorisation details

EMA product number
EMEA/H/C/001236

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder
Teva Pharma B.V. 

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

Opinion adopted
18/11/2010
Marketing authorisation issued
28/02/2011
Revision
16

Assessment history

Lamivudine/Zidovudine Teva : EPAR - Procedural steps taken and scientific information after authorisation

Lamivudine/Zidovudine Teva : EPAR - Public assessment report

CHMP summary of positive opinion for Lamivudine/Zidovudine Teva

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