Revised: 31 May 2019

Medicines

 

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
Remuera
Auckland 1541
1/9/2016Consent given
Approval date: 23/11/2017
Notification date: 1/3/2019
Prescription
Reference product: Truvada Tablet 300mg/200mg

Composition

ComponentIngredientManufacturer
film coated tabletActive 
 Emtricitabine 200 mgShanghai Desano Chemical Pharmaceutical Co., Ltd. Binhai site
No. 417 Binhai Road
Pudong
Shanghai 201302
China
 Tenofovir disoproxil succinate 300.6 mg (equiv to tenofovir disoproxil 245mg)Zhejiang Jiuzhou Pharmaceutical Co. Limited
99 Waisha Road
Jiaojiang District
Taizhou City
Zhejiang Province 318 000
China
 Excipient 
 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

Production

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

Packaging

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

Indications

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
22/11/2018Changed Medicine NotificationActive ingredient manufacturing process - Grade 2Granted 29/1/201930/11/2018 
2/5/2018CMN 24(5)Active ingredient manufacturing process - Grade 2; Administrative fee (CMN)Information requested 27/6/201914/5/2018 
1/9/2016New Intermediate-risk Medicine ApplicationAbridged new intermediate-risk prescription medicineGranted 23/11/20179/9/2016 
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