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docetaxel

Taxotere · ATC code L01CD02

Brand names: Taxotere, Docetaxel Ebewe, Docetaxel Hikma, Bendadocel, Doce, Docetaxel Aqvida, Docetaxel Aurobindo, Docetaxel Cell Pharm, Docetaxel Ever Pharma, Docetaxel Ever Valinject, Docetaxel Kelix Bio, Docetaxel Nordic, Docetaxel Phares, Docetaxel Ratiopharm, Docetaxel Seacross …

Key facts
Active substance
docetaxel
Drug class
Taxane
ATC code
L01CD02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
TAXOTERE 20 mg/0.5 mL concentrate and solvent for solution for infusion · TAXOTERE 80 mg/2 mL concentrate and solvent for solution for infusion · TAXOTERE 20 mg/1 mL concentrate for solution for infusion · TAXOTERE 80 mg/4 mL concentrate for solution for infusion · TAXOTERE 160 mg/8 mL concentrate for solution for infusion.
Marketing authorisation holder
Sanofi Winthrop Industrie
Information as of
2026-10-27

Key facts

Docetaxel is a taxane cytotoxic agent. It is used alone or in combination for breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer.

What it is used for

  • Breast cancer: adjuvant (with doxorubicin and cyclophosphamide), locally advanced or metastatic alone or with doxorubicin, trastuzumab (HER2-positive) or capecitabine
  • Non-small cell lung cancer: after failure of prior chemotherapy, or first-line with cisplatin
  • Metastatic castration-resistant prostate cancer (with prednisone/prednisolone) and metastatic hormone-sensitive prostate cancer (with androgen-deprivation therapy)
  • Metastatic gastric adenocarcinoma (with cisplatin and 5-fluorouracil)
  • Induction treatment of locally advanced squamous cell carcinoma of the head and neck (with cisplatin and 5-fluorouracil)

Dosing

  • One-hour infusion every three weeks; only in specialised units under supervision of a physician qualified in anticancer chemotherapy
  • Adjuvant breast cancer (TAC): 75 mg/m² after doxorubicin and cyclophosphamide, every 3 weeks for 6 cycles; monotherapy 100 mg/m²; with trastuzumab 100 mg/m²; with doxorubicin or capecitabine 75 mg/m²
  • NSCLC: 75 mg/m² followed by cisplatin, or 75 mg/m² as a single agent after platinum-based therapy
  • Prostate cancer: 75 mg/m² with prednisone or prednisolone 5 mg twice daily
  • Premedication with an oral corticosteroid (e.g. dexamethasone; schedule depends on indication)
  • Hepatic impairment: dose reduction or no use depending on laboratory values; further schemes and dose adjustments in the full text

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Baseline neutrophil count below 1,500 cells/mm³
  • Severe liver impairment
  • Contraindications of combined medicines also apply

Important warnings

  • Neutropenia is the most frequent adverse reaction; frequent blood counts, retreat only when neutrophils recover to 1,500 cells/mm³
  • Hypersensitivity reactions, especially during the first and second infusions; stop immediately for severe reactions
  • Fluid retention (pleural or pericardial effusion, ascites)
  • Respiratory disorders (e.g. interstitial pneumonia, ARDS), possibly fatal
  • Serious gastrointestinal toxicity and heart failure can occur; the product contains alcohol

Side effects

  • Most common with docetaxel alone: neutropenia, anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia
  • Severity may increase when combined with other chemotherapeutic agents

Interactions

  • CYP3A inducers, inhibitors or substrates (e.g. cyclosporine, ketoconazole, erythromycin) may modify metabolism
  • Avoid strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, ritonavir, voriconazole)
  • Alcohol content may alter the effects of other medicines

Pregnancy and breastfeeding

  • Women of childbearing potential must use effective contraception during and for 2 months after treatment, men for 4 months after
  • Breast-feeding must be discontinued during therapy

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)

  • Docetaxel Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/002539
  • Docetaxel Kabi · genericFresenius Kabi Deutschland GmbH · EMEA/H/C/002325
  • TaxotereSanofi Winthrop Industrie · EMEA/H/C/000073

Source: European Medicines Agency (EMA), product information

Austria

  • Docetaxel EbeweEbewe Pharma · 1 register entry
  • Docetaxel HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry

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

Germany

  • BendadocelBendalis Gmbh · 1 register entry
  • DoceOnkovis Gmbh · 1 register entry
  • Docetaxel AqvidaAqvida Gmbh · 1 register entry
  • Docetaxel AurobindoEugia Pharma (Malta) Limited · 1 register entry
  • Docetaxel Cell PharmStadapharm Gmbh · 1 register entry
  • Docetaxel Ever PharmaEver Valinject Gmbh · 1 register entry
  • Docetaxel Ever ValinjectEver Valinject Gmbh · 1 register entry
  • Docetaxel HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry
  • Docetaxel Kelix BioKelix Bio (Malta) Limited · 1 register entry
  • Docetaxel NordicNordic Group B.V. · 1 register entry
  • Docetaxel PharesPharma Resources Gmbh · 1 register entry
  • Docetaxel RatiopharmRatiopharm Gmbh · 1 register entry
Show all 15 brand names
  • Docetaxel SeacrossSeacross Pharma (Europe) Ltd · 1 register entry
  • Docetaxel StadaStadapharm Gmbh · 1 register entry
  • Docetaxel ZentivaZentiva Pharma Gmbh · 1 register entry

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

Turkey

  • DoceterFARMAKO ECZACILIK A.Ş. · 7 register entries
  • DocetuONKO İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • DocexusPHARMADA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • DoxelGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 8 register entries
  • DoxitaxKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 8 register entries
  • SantaxSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • TadocelVEM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

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

Brand names in 25 more European countries
Belgium
Docetaxel Eugia, Docetaxel Hikma
Bulgaria
Доцетаксел Булгермед, Доцетаксел Новамед
Croatia
Docetaksel Teva, Docetaksel Zentiva
Czechia
Docetaxel Ebewe
Denmark
Docetaxel Ebewe, Docetaxel Stada
Estonia
Docetaxel Ebewe
Finland
Docetaxel Ebewe
France
Docetaxel Arrow, Docetaxel Hikma, Docetaxel Hospira, Docetaxel Seacross
Greece
Demotaxel, Docetaxel Actavis, Docetaxel Hospira, Doxen, Taxovina
Hungary
Docetaxel Seacross
Iceland
Docetaxel Accord, Docetaxel Kabi, Taxotere
Italy
Docetaxel Aurobindo, Docetaxel Hikma, Docetaxel Ratiopharm
Liechtenstein
Docetaxel Accord, Docetaxel Kabi, Taxotere
Lithuania
Docetaxel Ebewe, Docetaxel Sanoswiss
Luxembourg
Docetaxel Eugia
Malta
Docetaxel Hospira
Netherlands
Demotaxel Mono, Docetaxel Eugia, Docetaxel Hikma, Docetaxel Seacross
Norway
Docetaxel Accord, Docetaxel Ebewe, Docetaxel Kabi, Taxotere
Poland
Docetaxel Ebewe
Portugal
Docetaxel Aurovitas, Docetaxel Hikma, Docetaxel Seacross
Romania
Docetaxel Teva
Slovakia
Docetaxel Sandoz
Slovenia
Docetaksel Sandoz
Spain
Docetaxel Aurovit, Docetaxel Aurovitas, Docetaxel Glenmark, Docetaxel Hikma, Docetaxel Hospira, Docetaxel Seacross, Docetaxel Tillomed
Sweden
Docetaxel Actavis, Docetaxel Ebewe

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. Taxotere – 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/taxotere-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
  5. Wikidata (CC0): ATC L01CD.

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.