EXVIERA Film-coated tablet Ref.[8766] Active ingredients: Dasabuvir

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Product name and form

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’.

Qualitative and quantitative composition

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))
Lactose monohydrate
Copovidone
Croscarmellose sodium
Colloidal anhydrous silica (E551)
Magnesium stearate (E470b)

Film-coating:

Poly(vinyl alcohol) (E1203)
Titanium dioxide (E171)
Macrogol (3350)
Talc (E553b)
Iron oxide yellow (E172)
Iron oxide red (E172)
Iron oxide black (E172)

Pack sizes and marketing

PVC/PE/PCTFE aluminium foil blister packs.

Pack-size of 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).

Marketing authorization holder

AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Marketing authorization dates and numbers

EU/1/14/983/001

Date of first authorisation: 15 January 2015

Drugs

Drug Countries
EXVIERA Austria, Cyprus, Estonia, Finland, Ireland, Lithuania, Poland, Romania, Tunisia, Turkey

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