Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10010a
Trade NameDose FormStrengthIdentifier
DescovyFilm coated tablet200mg/25mg
SponsorApplication dateRegistration situationClassification
Gilead Sciences (NZ)
c/- Grant Thornton New Zealand Limited
L4, 152 Fanshawe Street
PO Box 1961
Auckland 1140
13/7/2016Consent given
Approval date: 16/2/2017
Notification date: 22/9/2020
Prescription
 

Composition

ComponentIngredientManufacturer
tabletActive 
 Emtricitabine 200 mgEsteve 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 28 mg equivalent to 25 mg Tenofovir alafenamideEsteve 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 stepManufacturer
Finished Product TestingEurofins 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 - MicrobiologicalSGS Institut Fresenius GmbH
Im Maisel 14
Taunusstein D-65232
Germany
Manufacture of Final Dose FormPatheon Inc
Toronto Region Operations (TRO)
2100 Syntex Court
Mississauga
Ontario L5N 7K9
Canada
 Rottendorf Pharma GmbH
Ostenfelder Strasse 51 - 61
Ennigerloh 59320
Germany
PackingAndersonBrecon 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
Ireland
 Patheon Inc
Toronto Region Operations (TRO)
2100 Syntex Court
Mississauga
Ontario L5N 7K9
Canada
Secondary PackagingRottendorf Pharma GmbH
Am Fleigendahl 3
Ennigerloh 59320
Germany
NZ Site of Product ReleaseGilead Sciences (NZ)
c/- PricewaterhouseCoopers
Level 8 Pricewaterhousecoopers Tower
188 Quay Street
AUCKLAND 1010

Packaging

PackageContentsShelf Life
Bottle, plastic, 60 mL HDPE white bottle with PP CRC cap lined with an induction activated al foil liner30 tablets48 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 DateApplication TypeChange(s)StatusPayment DatePriority
26/8/2020Changed Medicine NotificationShelf life/storage conditions - Grade 2; Finished product specifications/test methods - Grade 5; Administrative fee (CMN)Granted 7/10/20208/9/2020 
13/7/2016New Higher-risk Medicine ApplicationAbridged new higher-risk medicine not containing a new active substanceGranted 16/2/201726/7/2016 
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /