COMBIVIR Film-coated tablet Ref.[10508] Active ingredients: Lamivudine Zidovudine Zidovudine and Lamivudine

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Product name and form

Combivir 150 mg/300 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White to off-white, capsule-shaped film-coated scored tablets engraved with “GXFC3” on both sides.

Qualitative and quantitative composition

Each film-coated tablet contains 150 mg lamivudine and 300 mg zidovudine.

Excipient(s) with known effect: Each 150/300 mg tablet contains 0.945 mg sodium.

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.

Zidovudine

Zidovudine is an antiviral agent which is highly active in vitro against retroviruses including the Human Immunodeficiency Virus (HIV).

Zidovudine and Lamivudine

Lamivudine and zidovudine are nucleoside analogues which have activity against HIV. Additionally, lamivudine has activity against hepatitis B virus (HBV). Both medicinal products are metabolised intracellularly to their active moieties, lamivudine 5'-triphosphate (TP) and zidovudine 5'-TP respectively. Their main modes of action are as chain terminators of viral reverse transcription.

List of Excipients

Tablet core:

Microcrystalline cellulose (E460)
Sodium starch glycollate
Colloidal silicon dioxide
Magnesium stearate

Tablet film coat:

Hypromellose (E464)
Titanium dioxide (E171)
Macrogol 400
Polysorbate 80

Pack sizes and marketing

Cartons containing opaque polyvinyl chloride/foil blister packs. Cartons containing white high density polyethylene (HDPE) bottle with a child-resistant closure. Each pack type contains 60 film-coated tablets.

Marketing authorization holder

ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Marketing authorization dates and numbers

EU/1/98/058/001
EU/1/98/058/002

Date of first authorisation: 18 March 1998
Date of renewal authorisation: 13 February 2008

Drugs

Drug Countries
COMBIVIR Austria, Australia, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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