Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Exviera 250 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Beige, ovaloid, film-coated tablets with dimensions of 14.0 mm x 8.0 mm and debossed on one side with ‘AV2’. |
Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Excipient with known effect: Each film-coated tablet contains 45 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dasabuvir |
Dasabuvir is a non-nucleoside inhibitor of the HCV RNA-dependent RNA polymerase encoded by the NS5B gene, which is essential for replication of the viral genome. Co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir combines three direct-acting antiviral medicinal products with distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460(i)) Film-coating: Poly(vinyl alcohol) (E1203) |
PVC/PE/PCTFE aluminium foil blister packs.
Pack-size of 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
EU/1/14/983/001
Date of first authorisation: 15 January 2015
| Drug | Countries | |
|---|---|---|
| EXVIERA | Austria, Cyprus, Estonia, Finland, Ireland, Lithuania, Poland, Romania, Tunisia, Turkey |
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