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sorafenib

Nexavar · ATC code L01EX02

Brand names: Nexavar, Sorafenib Abz, Sorafenib Al, Sorafenib Beta, Sorafenib Bluefish, Sorafenib Heumann, Sorafenib Ratiopharm, Sorafenib Stada, Prokinib, Sofexan

Key facts
Active substance
sorafenib
ATC code
L01EX02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Nexavar 200 mg film-coated tablets
Marketing authorisation holder
Bayer AG
Information as of
2026-10-27

Key facts

Sorafenib (Nexavar) is a multikinase inhibitor for hepatocellular carcinoma, advanced renal cell carcinoma and radioactive iodine-refractory differentiated thyroid carcinoma.

What it is used for

  • Hepatocellular carcinoma
  • Advanced renal cell carcinoma after failure of, or unsuitability for, interferon-alpha or interleukin-2 based therapy
  • Progressive, locally advanced or metastatic differentiated thyroid carcinoma refractory to radioactive iodine

Dosing

  • Adults: 400 mg (two 200 mg tablets) twice daily, total daily dose 800 mg
  • Continue as long as clinical benefit is observed or until unacceptable toxicity
  • Dose reduction in HCC and RCC: two 200 mg tablets once daily
  • Dose reduction in thyroid carcinoma stepwise to 600 mg, 400 mg and, if needed, 200 mg daily
  • Take without food or with a low or moderate fat meal; with a high-fat meal, at least 1 hour before or 2 hours after
  • No adjustment in Child Pugh A or B; no data for Child Pugh C

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Hand foot skin reaction and rash, usually in the first six weeks
  • Arterial hypertension; monitor blood pressure regularly
  • Aneurysms and artery dissections, haemorrhage, cardiac ischaemia and/or infarction
  • QT prolongation; wound healing complications (interrupt before major surgery)

Side effects

  • Most common: diarrhoea, fatigue, alopecia, infection, hand foot skin reaction, rash
  • Serious: myocardial infarction/ischaemia, gastrointestinal perforation, drug induced hepatitis, haemorrhage, hypertensive crisis

Interactions

  • Rifampicin and other CYP3A4/glucuronidation inducers (e.g. St. John's wort, phenytoin, carbamazepine) lower levels
  • Warfarin or phenprocoumon: monitor INR and bleeding regularly
  • Caution with UGT1A1/UGT1A9 substrates (e.g. irinotecan) and with docetaxel
  • Neomycin and other antibiotics may reduce bioavailability

Pregnancy and breastfeeding

  • Not to be used in pregnancy unless clearly necessary; women of childbearing potential must use effective contraception

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.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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)

Source: European Medicines Agency (EMA), product information

Austria

  • SorafenibStada Arzneimittel Gmbh, Bluefish Pharmaceuticals Ab, Sandoz Gmbh, G.L. Pharma Gmbh · 4 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Sorafenib AbzRatiopharm Gmbh · 1 register entry
  • Sorafenib AlAliud Pharma Gmbh · 1 register entry
  • Sorafenib BetaBetapharm Arzneimittel Gmbh · 1 register entry
  • Sorafenib BluefishBluefish Pharmaceuticals Ab · 1 register entry
  • Sorafenib HeumannTorrent Pharma (Malta) Ltd · 1 register entry
  • Sorafenib RatiopharmRatiopharm Gmbh · 1 register entry
  • Sorafenib StadaStadapharm Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • NexavarBAYER TÜRK KİMYA SAN. LTD. ŞTİ. · 1 register entry
  • ProkinibBİEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • SofexanNOBEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 27 more European countries
Belgium
Sorafenib Eg, Sorafenib Eurogenerics, Sorafenib Sandoz, Sorafénib Eg
Bulgaria
Сорафениб Тева, Сорафениб Фармасайънс
Croatia
Sorafenib Alpha-Medical, Sorafenib Pharmascience, Sorafenib Sandoz, Sorafenib Stada, Sorafenib Teva, Sorevar
Cyprus
Rexanib
Czechia
Sorafenib Pharmagen, Sorafenib Sandoz, Sorafenib Stada
Denmark
Sorafenib "sandoz", Sorafenib Stada, Sorafenib Viatris
Estonia
Sorafenib Sandoz, Sorafenib Teva, Xorafia
Finland
Sorafenib Sandoz, Sorafenib Stada, Sorafenib Viatris
France
Sorafenib Biogaran, Sorafenib Eg, Sorafenib Sandoz, Sorafenib Teva, Sorafenib Viatris
Greece
Revamox, Sorafenib Bioars, Sorafenib Sandoz, Sorafenib Teva
Hungary
Renixola, Revamox, Soracell, Sorafenib G.L. Pharma, Sorafenib Pharmascience, Sorafenib Stada, Sorafenib Teva, Soratina, Sorevar
Iceland
Nexavar, Sorafenib
Italy
Sorafenib Eg, Sorafenib Mylan, Sorafenib Teva
Latvia
Sorafenib Lv System, Sorafenib Sandoz, Sorafenib Teva
Liechtenstein
Nexavar, Sorafenib Accord
Lithuania
Sorafenib Sandoz, Xorafia
Luxembourg
Sorafenib Eg, Sorafenib Eurogenerics
Malta
Revamox, Sorafenib Pharos, Sorafenib Torrent
Netherlands
Sorafenib Betapharm, Sorafenib G.L. Pharma, Sorafenib Sandoz, Sorafenib Stada, Sorafenib Teva, Weldinin
Norway
Nexavar, Sorafenib Accord, Sorafenib Stada, Sorafenib Viatris
Poland
Sorafenib G.L., Sorafenib Sandoz, Sorafenib Stada
Portugal
Sorafenib
Romania
Sorafenib Dr. Reddy's, Sorafenib Sandoz, Sorafenib Stada
Slovakia
Sorafenib
Slovenia
Sorafenib Sandoz, Sorevar
Spain
Sorafenib Dr. Reddys, Sorafenib Stada, Sorafenib Viatris
Sweden
Sorafenib Bluefish, Sorafenib Sandoz, Sorafenib Stada, Sorafenib Teva, Sorafenib Viatris

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Nexavar – 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/nexavar-epar-product-information_en.pdf
  2. 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
  3. 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
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

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.