MAVIRET Coated granules Ref.[51252] Active ingredients: Glecaprevir and Pibrentasvir

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Product name and form

Maviret 50 mg/20 mg coated granules in sachet.

Pharmaceutical Form

Coated granules.

Pink and yellow granules.

Qualitative and quantitative composition

Each sachet contains 50 mg glecaprevir and 20 mg pibrentasvir.

Excipient with known effect: Each sachet of coated granules contains 26 mg of lactose (as monohydrate) and 4 mg propylene glycol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Glecaprevir and Pibrentasvir

Glecaprevir/Pibrentasvir is a fixed-dose combination of two pan-genotypic, direct-acting antiviral agents, glecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NS5A inhibitor), targeting multiple steps in the HCV viral lifecycle.
List of Excipients

Granule core:

Copovidone
Tocofersolan
Propylene glycol monocaprylate
Colloidal silicon dioxide
Croscarmellose sodium (in the glecaprevir granules only)
Sodium stearyl fumarate

Granule coating:

Hypromellose (E464)
Lactose monohydrate
Titanium dioxide
Macrogol
Iron oxide red (E172)
Iron oxide yellow (E172)

Pack sizes and marketing

Maviret coated granules are supplied in polyethylene terephthalate (PET)/aluminium/polyethylene film sachets in cartons. Each carton contains 28 sachets.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/17/1213/003

Date of first authorisation: 26 July 2017
Date of latest renewal: 22 March 2022

 
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