ZEFFIX Film-coated tablet Ref.[109670] Active ingredients: Lamivudine

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Zeffix 100 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Butterscotch coloured, film-coated, capsule shaped, biconvex, approximate dimensions 11mm x 5mm and engraved “GX CG5” on one face.

Qualitative and quantitative composition

Each film-coated tablet contains 100 mg lamivudine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lamivudine

Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Its main mode of action is as a chain terminator of viral reverse transcription.

List of Excipients

Tablet core:

Microcrystalline cellulose
Sodium starch glycolate
Magnesium stearate

Tablet film coat:

Hypromellose
Titanium dioxide
Macrogol 400
Polysorbate 80
Synthetic yellow and red iron oxides

Pack sizes and marketing

Double foil blisters, laminated with polyvinyl chloride.

Pack sizes of 28 or 84 film-coated tablets.

Not all pack-sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

EU/1/99/114/001
EU/1/99/114/002

Date of first authorisation: 29 July 1999
Date of latest renewal: 23 June 2014

Drugs

Drug Countries
ZEFFIX Austria, Australia, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.