emtricitabine/tenofovir disoproxil
Truvada · ATC code J05AR03
Also known as: Emtricitabin/Tenofovirdisoproxil, Emtricitabine / Tenofovir Disoproxil · Brand names: Truvada, Emtricitabin/Tenofovir Sandoz, Emtricitabin/Tenofovirdisoproxil Stada, Emtricitabin/Tenofovirdisoproxil Tillomed, Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Ratiopharm, Emtenovo, Emtricitabin Tenofovirdisoproxil Zentiva, Emtricitabin/Tenofovirdisoproxil Abdi, Emtricitabin/Tenofovirdisoproxil Al, Emtricitabin/Tenofovirdisoproxil Amarox, Emtricitabin/Tenofovirdisoproxil Beta, Emtricitabin/Tenofovirdisoproxil Cipla, Emtricitabin/Tenofovirdisoproxil Heumann, Emtricitabin/Tenofovirdisoproxil Hormosan …
- Key facts
- Active substance
- emtricitabine/tenofovir disoproxil (INN: emtricitabine / tenofovir disoproxil)
- Drug class
- Efavirenz/lamivudine/tenofovir
- ATC code
- J05AR03
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Truvada 200 mg/245 mg film-coated tablets
- Marketing authorisation holder
- Gilead Sciences Ireland UC
- Information as of
- 2026-10-27
Key facts
Emtricitabine/tenofovir disoproxil combines two nucleoside/nucleotide reverse transcriptase inhibitors for treatment of HIV-1 infection and pre-exposure prophylaxis (PrEP).
What it is used for
- Treatment of HIV-1 infection in adults as part of antiretroviral combination therapy
- HIV-1 infected adolescents when NRTI resistance or toxicities preclude first-line agents
- PrEP combined with safer sex practices in adults and adolescents at high risk
Dosing
- Treatment and PrEP (aged 12 and older, at least 35 kg): one tablet once daily
- Missed dose within 12 hours: take as soon as possible; vomiting within 1 hour: take another tablet
- Treatment with CrCl 30-49 mL/min: every 48 hours; CrCl < 30 mL/min and haemodialysis: not recommended
- PrEP not recommended with CrCl < 60 mL/min
- No dose adjustment in the elderly or hepatic impairment
Contraindications
- Hypersensitivity to the active substances or any excipient
- PrEP in individuals with unknown or positive HIV-1 status
Important warnings
- PrEP only in confirmed HIV-negative individuals, re-tested frequently, as resistance can emerge
- PrEP only as part of an overall prevention strategy, e.g. condom use and STI testing
- Renal impairment up to renal failure and Fanconi syndrome; creatinine clearance before starting and regularly
- Bone abnormalities such as osteomalacia and reduced bone mineral density
- HBV co-infection: severe exacerbations of hepatitis possible after discontinuation
Side effects
- HIV treatment: most frequently nausea and diarrhoea
- PrEP: headache most frequent; no new adverse reactions
- Renal effects and bone abnormalities with tenofovir disoproxil
Interactions
- Not with other products containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide or cytidine analogues such as lamivudine
- Not with adefovir dipivoxil
- Low potential for CYP450-mediated interactions
Pregnancy and breastfeeding
- A large amount of data shows no malformations; use in pregnancy may be considered if necessary
- Not during breast-feeding; women living with HIV are advised not to breast-feed
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Emtricitabine/Tenofovir disoproxil Krka · genericKRKA, d.d., Novo mesto · EMEA/H/C/004215
- Emtricitabine/Tenofovir disoproxil Krka d.d. · genericKRKA, d.d., Novo mesto · EMEA/H/C/004686
- Emtricitabine/Tenofovir disoproxil Mylan · genericMylan Pharmaceuticals Limited · EMEA/H/C/004050
- Emtricitabine/Tenofovir disoproxil Zentiva · genericZentiva k.s. · EMEA/H/C/004137
- TruvadaGilead Sciences Ireland UC · EMEA/H/C/000594
Source: European Medicines Agency (EMA), product information
Austria
- Emtricitabin/Tenofovir SandozSandoz Gmbh · 1 register entry
- Emtricitabin/Tenofovirdisoproxil StadaStada Arzneimittel Gmbh · 1 register entry
- Emtricitabin/Tenofovirdisoproxil TillomedTillomed Pharma Gmbh · 1 register entry
- Emtricitabine/Tenofovir Disoproxil AccordpharmaAccord Healthcare B.V. · 1 register entry
- Emtricitabine/Tenofovir Disoproxil RatiopharmTeva B.V · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- EmtenovoTad Pharma Gmbh · 1 register entry
- Emtricitabin Tenofovirdisoproxil ZentivaZentiva Pharma Gmbh · 1 register entry
- Emtricitabin/Tenofovirdisoproxil AbdiAbdi Farma Gmbh · 1 register entry
- Emtricitabin/Tenofovirdisoproxil AlAliud Pharma Gmbh · 1 register entry
- Emtricitabin/Tenofovirdisoproxil AmaroxAmarox Pharma Gmbh · 1 register entry
- Emtricitabin/Tenofovirdisoproxil BetaBetapharm Arzneimittel Gmbh · 1 register entry
- Emtricitabin/Tenofovirdisoproxil CiplaCipla Europe Nv · 1 register entry
- Emtricitabin/Tenofovirdisoproxil HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
- Emtricitabin/Tenofovirdisoproxil HormosanHormosan Pharma Gmbh · 1 register entry
- Emtricitabin/Tenofovirdisoproxil PurenPuren Pharma Gmbh & Co. Kg · 1 register entry
- Emtricitabin/Tenofovirdisoproxil RatiopharmRatiopharm Gmbh · 1 register entry
- OremtenOresund Pharma Aps · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- HiventİLKO İLAÇ SAN.VE TİC. A.Ş. · 2 register entries
- PernoiSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- SidatriaSANOFİ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- TruventHUMANİS SAĞLIK A.Ş. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 23 more European countries
- Belgium
- Emtricitabin/Tenofovir Disoproxil Ab
- Croatia
- Emtricitabin/Tenofovirdizoproksil Pliva
- Cyprus
- Exatron
- Denmark
- Emtricitabin/Tenofovirdisoproxil Tillomed, Emtricitabine/Tenofovir Disoproxil "sandoz", Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Glenmark, Emtricitabine/Tenofovir Disoproxil Stada, Emtricitabine/Tenofovir Disoproxil Teva, Oremten
- Estonia
- Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Sandoz, Emtricitabine/Tenofovir Disoproxil Teva, Emtricitabine/Tenofovir Zentiva
- Finland
- Emtricitabine / Tenofovir Disoproxil Stada, Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Sandoz, Emtricitabine/Tenofovir Disoproxil Tillomed
- France
- Emtricitabine/ Tenofovir Disoproxil Sandoz, Emtricitabine/Tenofovir Disoproxil Accord, Emtricitabine/Tenofovir Disoproxil Arrow, Emtricitabine/Tenofovir Disoproxil Biogaran, Emtricitabine/Tenofovir Disoproxil Cipla, Emtricitabine/Tenofovir Disoproxil Eg, Emtricitabine/Tenofovir Disoproxil Evolugen, Emtricitabine/Tenofovir Disoproxil Teva, Emtricitabine/Tenofovir Disoproxil Zentiva Lab, Emtricitabine/Tenofovir Disoproxil Zydus
- Greece
- Argiodin, Emtricitabin/Tenofovir Disoproxil Accord, Valdevon
- Hungary
- Dunotrisin, Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir-Disoproxil Teva, Tabinera
- Iceland
- Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Krka, Emtricitabine/Tenofovir Disoproxil Mylan, Emtricitabine/Tenofovir Disoproxil Sandoz, Emtricitabine/Tenofovir Disoproxil Zentiva, Truvada
- Ireland
- Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Clonmel, Emtricitabine/Tenofovir Disoproxil Teva, Emtricitabine/Tenofovir Disoproxil Tillomed
- Italy
- Emtricitabina E Tenofovir Disoproxil Aequilibrium Pharma, Emtricitabina E Tenofovir Disoproxil Aurobindo, Emtricitabina E Tenofovir Disoproxil Doc Generici, Emtricitabina E Tenofovir Disoproxil Teva
- Latvia
- Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Teva, Emtricitabine/Tenofovir Disoproxil Unifarma
- Liechtenstein
- Emtricitabine/Tenofovir Disoproxil Mylan, Emtricitabine/Tenofovir Disoproxil Zentiva, Truvada
- Lithuania
- Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Sandoz
- Netherlands
- Emtricitabine Tenofovir Disoproxyl Fumarate Aurobindo, Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovirdisoproxil Accord, Emtricitabine/Tenofovirdisoproxil Amarox, Emtricitabine/Tenofovirdisoproxil Doc Generici, Emtricitabine/Tenofovirdisoproxil Glenmark, Emtricitabine/Tenofovirdisoproxil Sandoz, Emtricitabine/Tenofovirdisoproxil Teva, Emtricitabine/Tenofovirdisoproxil Tillomed, Valdevon
- Norway
- Emtricitabin/Tenofovirdisoproxil Tillomed, Emtricitabine/ Tenofovir Disoproxil Cipla, Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Krka, Emtricitabine/Tenofovir Disoproxil Mylan, Emtricitabine/Tenofovir Disoproxil Sandoz, Emtricitabine/Tenofovir Disoproxil Zentiva, Truvada
- Poland
- Emtricitabine + Tenofovir Disoproxil Aurovitas, Emtricitabine + Tenofovir Disoproxil Tillomed
- Portugal
- Emtricitabina + Tenofovir Accord, Emtricitabina + Tenofovir Disoproxil, Emtricitabina + Tenofovir Farmoz, Emtricitabina + Tenofovir Generis, Emtricitabina + Tenofovir Teva, Emtricitabina + Tenofovir Zentiva
- Romania
- Emtricitabină/Tenofovir Disoproxil Stada, Emtricitabină/Tenofovir Disoproxil Teva, Emtricitabină/Tenofovir Disoproxil Tillomed
- Slovenia
- Emtricitabin/Dizoproksiltenofovirat Teva
- Spain
- Emtricitabina/Tenofovir Disoproxilo Aurovitas, Emtricitabina/Tenofovir Disoproxilo Glenmark, Emtricitabina/Tenofovir Disoproxilo Macleods, Emtricitabina/Tenofovir Disoproxilo Tillomed, Emtricitabine/Tenofovir Disoproxil Teva
- Sweden
- Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Glenmark, Emtricitabine/Tenofovir Disoproxil Sandoz, Emtricitabine/Tenofovir Disoproxil Stada, Emtricitabine/Tenofovir Disoproxil Teva, Emtricitabine/Tenofovir Disoproxil Tillomed, Oremten
EMA – Article 57 product data (EU/EEA), 2026-10-28
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Sources
- European Medicines Agency. Truvada – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/truvada-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC J05AR.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.