Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| 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 |
