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Dasatinib

Dasatinib Accord Healthcare · ATC code L01EA02

Brand names: Daruph, Dasatinib G.L., Dasa-Abz, Dasatilen, Dafanib, Dasafix, Dasavec, Dasikam, Mylorge, Sprycel, Sprytinib

Key facts
Active substance
Dasatinib
ATC code
L01EA02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Dasatinib Accord Healthcare 20 mg film-coated tablets / Dasatinib Accord Healthcare 50 mg film-coated tablets / Dasatinib Accord Healthcare 70 mg film-coated tablets
Information as of
2026-10-27

Key facts

Dasatinib is a tyrosine kinase inhibitor for Philadelphia chromosome positive chronic myelogenous leukaemia (CML) and Ph+ acute lymphoblastic leukaemia (ALL) in adults and children.

What it is used for

  • Adults: newly diagnosed Ph+ CML in the chronic phase
  • Adults: chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib
  • Adults: Ph+ ALL and lymphoid blast CML with resistance or intolerance to prior therapy
  • Children: Ph+ CML in chronic phase (newly diagnosed or pre-treated) and newly diagnosed Ph+ ALL with chemotherapy

Dosing

  • Adults, chronic phase CML: 100 mg once daily
  • Adults, advanced phase CML or Ph+ ALL: 140 mg once daily
  • Children: dosed by body weight (table in full text), recalculated every 3 months
  • Tablets not recommended under 10 kg; tablets and powder for oral suspension are not bioequivalent
  • Dose adjustments for myelosuppression and other adverse reactions in the full text

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Myelosuppression; regular blood counts
  • Pleural effusion: interrupt treatment until the patient is examined
  • Pulmonary arterial hypertension (PAH) has been reported
  • Potential QT prolongation
  • Hepatitis B reactivation in chronic carriers on BCR-ABL tyrosine kinase inhibitors

Side effects

  • Most patients experienced adverse reactions at some time
  • Important: myelosuppression, fluid retention including pleural effusion, bleeding
  • Further reactions by frequency in the table in the full text

Interactions

  • Potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice) increase dasatinib exposure; not recommended
  • CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, St. John's Wort) reduce exposure
  • H2 antagonists and proton pump inhibitors not recommended; antacids should be separated in time

Pregnancy and breastfeeding

  • Suspected to cause congenital malformations including neural tube defects; use in pregnancy only if the clinical condition requires it
  • Sexually active men and women of childbearing potential should use effective contraception during treatment

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

  • DaruphZentiva, K.S. · 1 register entry
  • Dasatinib G.L.G.L. Pharma Gmbh · 1 register entry

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

Germany

  • DaruphZentiva Pharma Gmbh · 1 register entry
  • Dasa-AbzRatiopharm Gmbh · 1 register entry
  • DasatilenTad Pharma Gmbh · 1 register entry
  • Dasatinib1 A Pharma Gmbh, Ratiopharm Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Viatris Germany Gmbh, Vivanta Generics S.R.O., Zentiva Pharma Gmbh, Aliud Pharma Gmbh · 7 register entries

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

Turkey

  • DafanibDEVA HOLDİNG A.Ş. · 6 register entries
  • DasafixNOBEL İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • DasavecKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 3 register entries
  • DasikamTEVA İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • MylorgeABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • SprycelBRISTOL-MYERS SQUIBB İLAÇLARI INC. İSTANBUL ŞUBESİ · 4 register entries
  • SprytinibDEM İLAÇ SAN. VE TİC. A.Ş. · 4 register entries

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

Brand names in 28 more European countries
Belgium
Dasatinib Krka, Dasatinib Sandoz, Dasatinib Teva, Dasatinib Viatris
Bulgaria
Dasatinib Sandoz, Дазатиниб Зентива, Дазатиниб Тева, Нодрига
Croatia
Dasatinib Alpha-Medical, Dasatinib Stada, Dasatinib Teva, Dasatinib Zentiva, Nodriga
Cyprus
Dasatinib Teva, Specenib
Czechia
Daruph, Dasatinib Msn, Dasatinib Sandoz, Dasatinib Teva, Dasatinib Viatris
Denmark
Dasatinib "sandoz", Dasatinib Krka, Dasatinib Stada, Dasatinib Teva, Dasatinib Viatris, Dasatinib Vivanta, Dasatinib Zentiva
Estonia
Dasatinib Teva, Dasatinib Viatris, Dasatinib Zentiva
Finland
Dasatinib Avansor, Dasatinib Krka, Dasatinib Sandoz, Dasatinib Stada, Dasatinib Viatris
France
Dasatinib Arrow, Dasatinib Biogaran, Dasatinib Eg, Dasatinib Krka, Dasatinib Sandoz, Dasatinib Teva, Dasatinib Tillomed, Dasatinib Viatris, Dasatinib Vivanta, Dasatinib Zentiva, Dasatinib Zydus, Mubucho
Greece
Dasatinib Faran, Dasatinib Teva
Hungary
Daruph, Dasatinib Krka, Dasatinib Mylan, Dasatinib Onkogen, Dasatinib Sandoz, Dasatinib Stada, Dasatinib Teva, Dazatinib Sandoz
Iceland
Dasatinib Accord Healthcare, Dasatinib Krka, Dasatinib Mylan, Dasatinib Stada, Sprycel
Ireland
Dasatinib Clonmel, Dasatinib Krka, Dasatinib Teva, Mubucho
Italy
Dasatinib Aurobindo, Dasatinib Eg, Dasatinib Krka, Dasatinib Mylan, Dasatinib Sandoz, Dasatinib Zentiva
Latvia
Dasatinib Teva, Dasatinib Viatris, Dasatinib Zentiva
Liechtenstein
Dasatinib Accord, Sprycel
Lithuania
Dasatinib Krka, Dasatinib Teva, Dasatinib Viatris, Dasatinib Zentiva
Luxembourg
Dasatinib Teva, Dasatinib Viatris
Malta
Dasatinib Clonmel, Dasatinib Synthon
Netherlands
Dasatinib Cf, Dasatinib Krka, Dasatinib Sandoz, Dasatinib Synthon, Dasatinib Teva, Dasatinib Viatris, Dasatinib Vivanta, Dasatinib Zentiva
Norway
Dasatinib Accord Healthcare, Dasatinib Krka, Dasatinib Sandoz, Dasatinib Teva, Dasatinib Viatris, Sprycel
Poland
Daruph, Dasatinib Eugia, Dasatinib Sandoz, Dasatinib Stada, Dasatinib Sun, Dasatinib Viatris, Dasatinib Zentiva
Portugal
Dasatinib Eugia, Dasatinib Generis, Dasatinib Krka, Dasatinib Mylan, Dasatinib Sandoz, Dasatinib Teva, Dasatinib Zentiva, Mubucho
Romania
Dasatinib Krka, Dasatinib Msn, Dasatinib Sandoz, Dasatinib Stada, Dasatinib Sun, Dasatinib Teva, Dasatinib Zentiva, Nodriga
Slovakia
Daruph, Dasatinib Krka, Dasatinib Msn, Dasatinib Sandoz, Dasatinib Teva, Dasatinib Zentiva
Slovenia
Dasatinib Krka, Dasatinib Sandoz, Nodriga
Spain
Daruph, Dasatinib
Sweden
Daruph, Dasatinib, Mubucho

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. Dasatinib Accord Healthcare – 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/dasatinib-accord-healthcare-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.