Revised: 31 May 2019
Medicines
Medsafe Product Detail | ![]() ![]() | |
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File ref: TT50-10010a |
Trade Name | Dose Form | Strength | Identifier |
Descovy | Film coated tablet | 200mg/25mg | |
Sponsor | Application date | Registration situation | Classification |
Gilead Sciences (NZ) c/- Grant Thornton New Zealand Limited L4, 152 Fanshawe Street PO Box 1961 Auckland 1140 | 13/7/2016 | Consent given Approval date: 16/2/2017 Notification date: 22/9/2020 | Prescription |
Composition
Component | Ingredient | Manufacturer |
tablet | Active | |
Emtricitabine 200mg | Esteve Huayi Pharmaceutical Co Ltd Lin Hai Road SPIZ Shaoxing Zhejiang China | |
Union Quimico Farmaceutica SA (Uquifa SA) Factory No. 2 Poligon Industrial Moli de les Planes Carrer Font de Bocs S/N, C-35, Km.57 Sant Celoni, (Barcelona) 08470 Spain | ||
Evonik Nutrition and Care GmbH Gutenbergstrasse 2 Dossenheim 69921 Germany | ||
Yuhan Chemical Industries Co Ltd 45 Jiwon-ro, Danwon-gu Ansan-si Gyeonggi-do 15619 South Korea | ||
Gilead Alberta ULC 1021 Hayter Road Edmonton Alberta TS6 1A1 Canada | ||
Tenofovir alafenamide fumarate 28mg equivalent to 25 mg Tenofovir alafenamide | Esteve Quimica SA Poligon Industrial Celra Girona 17460 Spain | |
Gilead Alberta ULC 1021 Hayter Road Edmonton Alberta TS6 1A1 Canada | ||
Excipient | ||
Croscarmellose sodium | ||
Magnesium stearate | ||
Microcrystalline cellulose | ||
Opadry blue 85F105057 |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Eurofins Lancaster Laboratories Inc 2425 New Holland Pike Lancaster Pennsylvania 17601 United States of America |
Gilead Sciences Inc 333 Lakeside Drive Foster City California 94404 United States of America | |
Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill Co. Cork Ireland | |
Patheon Inc Toronto Region Operations (TRO) 2100 Syntex Court Mississauga Ontario L5N 7K9 Canada | |
Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 Ennigerloh 59320 Germany | |
Finished Product Testing - Microbiological | SGS Institut Fresenius GmbH Im Maisel 14 Taunusstein D-65232 Germany |
Manufacture of Final Dose Form | Patheon Inc Toronto Region Operations (TRO) 2100 Syntex Court Mississauga Ontario L5N 7K9 Canada |
Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 Ennigerloh 59320 Germany | |
Packing | AndersonBrecon Inc 4545 Assembly Drive Rockford Illinois 61109 United States of America |
Gilead Sciences Inc 650 Cliffside Drive San Dimas California 91773 United States of America | |
Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill Co. Cork Ireland | |
Millmount Healthcare Limited Block-7 City North Business Campus Stamullen County Meath K32 YD60 Ireland | |
Patheon Inc Toronto Region Operations (TRO) 2100 Syntex Court Mississauga Ontario L5N 7K9 Canada | |
Secondary Packaging | Rottendorf Pharma GmbH Am Fleigendahl 3 Ennigerloh 59320 Germany |
NZ Site of Product Release | Gilead Sciences (NZ) c/- PricewaterhouseCoopers Level 8 Pricewaterhousecoopers Tower 188 Quay Street AUCKLAND 1010 |
Packaging
Package | Contents | Shelf Life |
Bottle, plastic, 60 mL HDPE white bottle with PP CRC cap lined with an induction activated al foil liner | 30 tablets | 48 months from date of manufacture stored at or below 30°C |
Indications
DESCOVY is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with body weight at least 35 kg. The patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of DESCOVY.
DESCOVY is not for use in Pre-Exposure Prophylaxis (PrEP).
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
13/10/2022 | Changed Medicine Notification | Active ingredient manufacturing process - Grade 3; Administrative fee (CMN) | Granted 21/11/2022 | 25/10/2022 | |
13/7/2016 | New Higher-risk Medicine Application | Abridged new higher-risk medicine not containing a new active substance | Granted 16/2/2017 | 26/7/2016 |