Revised: 31 May 2019



Medsafe Product Detail

Data Sheet
File ref: TT50-10020
Trade NameDose FormStrengthIdentifier
Emtricitabine/Tenofovir disoproxilFilm coated tabletTeva
SponsorApplication dateRegistration situationClassification
Teva Pharma (New Zealand) Limited
P O Box 128 244
Auckland 1541
1/9/2016Consent given
Approval date: 23/11/2017
Notification date: 1/3/2019
Reference product: Truvada Tablet 300mg/200mg


film coated tabletActive 
 Emtricitabine 200mgShanghai Desano Chemical Pharmaceutical Co., Ltd. Binhai site
No. 417 Binhai Road
Shanghai 201302
 Tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245mgGranules India Limited
Plot No. 8, Jawaharlal Nehru Pharma City
Tadi Village, Parawada Mandal
Visakhapatnam District
Andhra Pradesh
  Zhejiang Jiuzhou Pharmaceutical Co. Limited
99 Waisha Road
Jiaojiang District
Taizhou City
Zhejiang Province 318 000
 Croscarmellose sodium
 Indigo carmine aluminium lake
 Lactose monohydrate
 Macrogol 3350
 Magnesium stearate
 Microcrystalline cellulose
 Polyvinyl alcohol
 Pregelatinised maize starch
 Purified talc
 Purified water
 Titanium dioxide


Manufacturing stepManufacturer
Finished Product TestingRemedica Ltd
Limassol Industrial Estate
Aharnon Street
Limassol 3056
Manufacture of Final Dose FormRemedica Ltd
Limassol Industrial Estate
Aharnon Street
Limassol 3056
PackingRemedica Ltd
Limassol Industrial Estate
Aharnon Street
Limassol 3056
NZ Site of Product ReleaseTeva Pharma (New Zealand) Limited
Level 14, 41 Shortland Street
Auckland 1010


PackageContentsShelf Life
Bottle, plastic, HDPE bottle with a PP Child Resistant Cap30 tablets48 months from date of manufacture stored at or below 25°C


Indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents.

Indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
8/12/2021Changed Medicine NotificationActive ingredient manufacturing process - Grade 3; Administrative fee (CMN)Granted 11/1/202213/12/2021 
1/9/2016New Intermediate-risk Medicine ApplicationAbridged new intermediate-risk prescription medicineGranted 23/11/20179/9/2016 
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