Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Epivir 150 mg film-coated tablets.
Epivir 300 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Epivir 150 mg film-coated tablets: Film-coated tablet. White, diamond shaped scored tablets engraved with “GX CJ7” on both faces. Epivir 300 mg film-coated tablets: Film-coated tablet. Grey, diamond shaped and engraved with “GX EJ7” on one face. |
Epivir 150 mg film-coated tablets: Each film-coated tablet contains 150 mg lamivudine.
Epivir 300 mg film-coated tablets: Each film-coated tablet contains 300 mg lamivudine.
Excipient(s) with known effect:
Each 150 mg tablet contains 0.378 mg sodium.
Each 300 mg tablet contains 0.756 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. |
| List of Excipients |
|---|
Epivir 150 mg Film-coated tabletsTablet core: Microcrystalline cellulose (E460) Tablet film-coat: Hypromellose (E464) Epivir 300 mg Film-coated tabletsTablet core: Microcrystalline cellulose (E460) Tablet film-coat: Hypromellose (E464) |
Epivir 150 mg Film-coated tablets: Child resistant HDPE bottles or PVC/aluminium foil blister packs each containing 60 tablets.
Epivir 300 mg Film-coated tablets: Child resistant HDPE bottles or PVC/aluminium foil blister packs each containing 30 tablets.
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Epivir 150 mg Film-coated tablets:
EU/1/96/015/001 (Bottle)
EU/1/96/015/004 (Blister pack)
Epivir 300 mg Film-coated tablets:
EU/1/96/015/003 (Bottle)
EU/1/96/015/005 (Blister pack)
Epivir 150 mg Film-coated tablets:
Date of first authorisation: 8 August 1996
Date of last renewal: 28 July 2006
Epivir 300 mg Film-coated tablets:
Date of first authorisation: 15 November 2001
Date of last renewal: 28 July 2006
| Drug | Countries | |
|---|---|---|
| EPIVIR | Austria, Brazil, Cyprus, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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