Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
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. |
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) Tablet film coat: Hypromellose (E464) |
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.
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
EU/1/98/058/001
EU/1/98/058/002
Date of first authorisation: 18 March 1998
Date of renewal authorisation: 13 February 2008
| Drug | Countries | |
|---|---|---|
| COMBIVIR | Austria, Australia, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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