Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-10126 |
Trade Name | Dose Form | Strength | Identifier |
Maviret | Film coated tablet | 100 mg / 40 mg | |
Sponsor | Application date | Registration situation | Classification |
AbbVie Limited P O Box 11437 Manners Street Wellington 6142 | 7/3/2017 | Consent given Approval date: 20/6/2018 | Prescription |
Composition
Component | Ingredient | Manufacturer |
film coated tablet | Active | |
Glecaprevir 100mg | AbbVie S.r.l S.R. 148 Pontina Km 52 Snc Campoverde di Aprilia Latina 04011 ITALY | |
AbbVie Ireland NL B.V. Manorhamilton Road Sligo IRELAND | ||
Pibrentasvir 40mg | AbbVie S.r.l S.R. 148 Pontina Km 52 Snc Campoverde di Aprilia Latina 04011 ITALY | |
AbbVie Ireland NL B.V. Manorhamilton Road Sligo IRELAND | ||
Excipient | ||
Colloidal silicon dioxide | ||
Copovidone | ||
Croscarmellose sodium | ||
Hypromellose | ||
Iron oxide red | ||
Lactose monohydrate | ||
Macrogol 3350 | ||
Propylene glycol monocaprylate | ||
Sodium stearyl fumarate | ||
Titanium dioxide | ||
Tocofersolan |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | AbbVie Deutschland GmbH & Co KG Knollstrasse Ludwigshafen 67061 GERMANY |
AbbVie Inc 1401 Sheridan Road North Chicago Illinois 60064-4000 UNITED STATES OF AMERICA | |
Fournier Laboratories Ireland Limited Anngrove Carrigtwohill County Cork IRELAND | |
Finished Product Testing - Microbiological | AbbVie Ireland NL B.V. Manorhamilton Road Sligo IRELAND |
Eurofins Biopharma Product Testing Ireland Limited Clogherane Dungarvan County Waterford X35 T628 IRELAND | |
Manufacture of Final Dose Form | AbbVie Deutschland GmbH & Co KG Knollstrasse Ludwigshafen 67061 GERMANY |
Fournier Laboratories Ireland Limited Anngrove Carrigtwohill County Cork IRELAND | |
Packing | AbbVie Deutschland GmbH & Co KG Knollstrasse Ludwigshafen 67061 GERMANY |
AbbVie Inc 1 North Waukegan Road North Chicago Illinois 60064 UNITED STATES OF AMERICA | |
Secondary Packaging | DHL Supply Chain (Australia) Pty Limited 25 Ottelia Road Kemps Creek NSW 2178 AUSTRALIA |
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 | |
UPS SCS Nederland BV Marco Poloweg 22-24 Venlo Limberg 5928 LE NETHERLANDS | |
Zuellig Pharma Specialty Solutions Group Pte Ltd 15 Changi North Way #01-02, #02-02, #02-10 498770 SINGAPORE | |
NZ Site of Product Release | AbbVie Limited 156-158 Victoria Street Wellington 6011 |
Packaging
Package | Contents | Shelf Life |
Blister pack, PVC/PE/PCTFE Al Foil Blister Packs, daily dosage requirement | 3 tablets | 60 months from date of manufacture stored at or below 30°C |
Blister pack, PVC/PE/PCTFE Al Foil Blister Packs, 21 tablets (7x3) for weekly use | 21 tablets | 60 months from date of manufacture stored at or below 30°C |
Blister pack, PVC/PE/PCTFE Al Foil Blister Packs, 4x21 tablets for monthly use | 84 tablets | 60 months from date of manufacture stored at or below 30°C |
Bottle, plastic, HDPE with CRC cap and desiccant | 84 tablets | 36 months from date of manufacture stored at or below 30°C |
Indications
MAVIRET is indicated for the treatment of adults and adolescents 12 years and older with chronic hepatitis C virus (HCV)
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
31/8/2023 | Changed Medicine Notification | Data sheet - G1; Data sheet - G2 | Granted 28/9/2023 | 5/9/2023 | |
7/3/2017 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances | Granted 20/6/2018 | 24/3/2017 |