MAVIRET Film-coated tablet Ref.[10436] Active ingredients: Glecaprevir Glecaprevir and Pibrentasvir Pibrentasvir

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

Product name and form

Maviret 100 mg/40 mg film-coated tablets.

Pharmaceutical Form
Film-coated tablet (tablet). Pink, oblong, biconvex, film-coated tablet of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘NXT’.

Qualitative and quantitative composition

Each film-coated tablet contains 100 mg glecaprevir and 40 mg pibrentasvir.

Excipient with known effect: Each film-coated tablet contains 7.48 mg lactose (as lactose monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Glecaprevir
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.
Pibrentasvir	Pibrentasvir is a pan-genotypic inhibitor of HCV nonstructural protein 5A (NS5A), which is essential for viral RNA replication and virion assembly.

List of Excipients
Tablet core: Copovidone (Type K 28) Vitamin E (tocopherol) polyethylene glycol succinate Silica, colloidal anhydrous Propylene glycol monocaprylate (Type II) Croscarmellose sodium Sodium stearyl fumarate Film coating: Hypromellose 2910 (E464) Lactose monohydrate Titanium dioxide Macrogol 3350 Iron oxide red (E172)

Pack sizes and marketing

PVC/PE/PCTFE aluminium foil blister packs.

Pack containing 84 (4 cartons of 21 tablets) film-coated tablets.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/17/1213/001

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

Drugs

Drug	Countries
MAVIRET	Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom

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