VIEKIRAX Film-coated tablet Ref.[108064] Active ingredients: Ombitasvir Ombitasvir, Paritaprevir and Ritonavir Paritaprevir Ritonavir

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Product name and form

Viekirax 12.5 mg/75 mg/50 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Pink, oblong, biconvex, film-coated tablets of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘AV1’.

Qualitative and quantitative composition

Each film-coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ombitasvir

Ombitasvir is an nonstructural protein 5A (NS5A) inhibitor that acts by inhibiting the HCV protein NS5A.

Ombitasvir, Paritaprevir and Ritonavir

Ombitasvir/paritaprevir/ritonavir, when co-administered with dasabuvir, 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. Ombitasvir is an inhibitor of HCV NS5A which is essential for viral replication. Paritaprevir is an inhibitor of HCV NS3/4A protease which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication. Ritonavir is not active against HCV. Ritonavir is a CYP3A inhibitor that increases the systemic exposure of the CYP3A substrate paritaprevir.

Paritaprevir
Ritonavir

Ritonavir is an orally active peptidomimetic inhibitor of the HIV-1 and HIV-2 aspartyl proteases. Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol polyprotein precursor which leads to the production of HIV particles with immature morphology that are unable to initiate new rounds of infection. Ritonavir has selective affinity for the HIV protease and has little inhibitory activity against human aspartyl proteases. Pharmacokinetic enhancement by ritonavir is based on ritonavir’s activity as a potent inhibitor of CYP3A-mediated metabolism.

List of Excipients

Tablet core:

Copovidone
Tocofersolan
Propylene glycol monolaurate
Sorbitan monolaurate
Colloidal anhydrous silica (E551)
Sodium stearyl fumarate

Film-coating:

Poly(vinyl alcohol) (E1203)
Macrogol (3350)
Talc (E553b)
Titanium dioxide (E171)
Iron oxide red (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/1/14/982/001

Date of first authorisation: 15 January 2015
Date of latest renewal: 19 September 2019

Drugs

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

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