Revised: 31 May 2019
Medicines
Medsafe Product Detail |  | |
|---|---|---|
| File ref: TT50-10020 |
| Trade Name | Dose Form | Strength | Identifier |
| Emtricitabine/Tenofovir disoproxil | Film coated tablet | Teva | |
| Sponsor | Application date | Registration situation | Classification |
| Teva Pharma (New Zealand) Limited P O Box 128 244 Remuera Auckland 1541 | 1/9/2016 | Consent given Approval date: 23/11/2017 Notification date: 1/3/2019 | Prescription |
| Reference product: Truvada Tablet 300mg/200mg | |||
Composition
| Component | Ingredient | Manufacturer |
| film coated tablet | Active | |
| Emtricitabine 200mg | Shanghai Desano Chemical Pharmaceutical Co., Ltd. Binhai site No. 417 Binhai Road Pudong Shanghai 201302 CHINA | |
| Tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245mg | Granules India Limited Plot No. 8, Jawaharlal Nehru Pharma City Tadi Village, Parawada Mandal Visakhapatnam District Andhra Pradesh INDIA | |
| 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 step | Manufacturer |
| Finished Product Testing | Remedica Ltd Limassol Industrial Estate Aharnon Street Limassol 3056 CYPRUS |
| Manufacture of Final Dose Form | Remedica Ltd Limassol Industrial Estate Aharnon Street Limassol 3056 CYPRUS |
| Packing | Remedica Ltd Limassol Industrial Estate Aharnon Street Limassol 3056 CYPRUS |
| NZ Site of Product Release | Teva Pharma (New Zealand) Limited Level 14, 41 Shortland Street Auckland 1010 |
Packaging
| Package | Contents | Shelf Life |
| Bottle, plastic, HDPE bottle with a PP Child Resistant Cap | 30 tablets | 48 months from date of manufacture 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 8/12/2021 | Changed Medicine Notification | Active ingredient manufacturing process - Grade 3; Administrative fee (CMN) | Granted 11/1/2022 | 13/12/2021 | |
| 1/9/2016 | New Intermediate-risk Medicine Application | Abridged new intermediate-risk prescription medicine | Granted 23/11/2017 | 9/9/2016 |
