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 |
