imatinib
Glivec · ATC code L01EA01
Brand names: Glivec, Imagerolan, Imanivec, Glimatine, Gliotin, Glitinib, Glivon, Imafen, Imagliv, Imatenil, Imatis, Imatra, Imavec, Maxinib, Nibtu …
- Key facts
- Active substance
- imatinib
- ATC code
- L01EA01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Glivec 100 mg film-coated tablets / Glivec 400 mg film-coated tablets
- Marketing authorisation holder
- Novartis Europharm Limited
- Information as of
- 2026-10-27
Key facts
Imatinib (Glivec) is a tyrosine kinase inhibitor. It is used in Philadelphia chromosome-positive CML and ALL, certain myeloproliferative and eosinophilic disorders, and gastrointestinal stromal tumours (GIST).
What it is used for
- Ph+ chronic myeloid leukaemia (CML) in adults and children, newly diagnosed or in advanced phases
- Ph+ acute lymphoblastic leukaemia (ALL): newly diagnosed with chemotherapy (adults and children); relapsed/refractory as monotherapy (adults)
- MDS/MPD with PDGFR gene re-arrangements; advanced hypereosinophilic syndrome and/or chronic eosinophilic leukaemia with FIP1L1-PDGFR rearrangement
- Kit-positive unresectable and/or metastatic GIST, and adjuvant treatment after resection at significant risk of relapse (adults)
- Further indications in the full product information
Dosing
- Taken with a meal and a large glass of water; 400 mg or 600 mg once daily, 800 mg as 400 mg twice a day
- CML chronic phase (adults): 400 mg/day; accelerated phase and blast crisis: 600 mg/day
- Dose increases (up to a maximum of 800 mg) may be considered for progression or inadequate response in the absence of severe adverse reactions
- CML in children: 340 mg/m2 daily (not to exceed a total dose of 800 mg)
- GIST (unresectable/metastatic): 400 mg/day
- Further regimens in the full product information
Contraindications
- Hypersensitivity to the active substance or any excipient
Important warnings
- Drug interactions: caution with CYP3A4 inhibitors, narrow-therapeutic-window CYP3A4 substrates and warfarin; avoid strong CYP3A4 inducers
- Severe fluid retention (pleural effusion, pulmonary oedema, ascites) in approximately 2.5% of newly diagnosed CML patients; weigh patients regularly
- Hepatotoxicity, including some fatal cases of hepatic failure
- Hypothyroidism in thyroidectomy patients on levothyroxine; monitor TSH
Side effects
- Most common (10% or more): mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps, rash
- Superficial oedema, mainly periorbital or lower limb
- Serious: GI and tumoural bleeding, hepatic failure, congestive heart failure
Interactions
- CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, ritonavir) may increase imatinib levels
- CYP3A4 inducers (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, St. John's Wort) may reduce efficacy
- Levothyroxine, warfarin and CYP3A4 substrates such as cyclosporine or tacrolimus
Pregnancy and breastfeeding
- Women of childbearing potential: effective contraception during treatment and for at least 15 days after stopping
- Not to be used in pregnancy unless clearly necessary; spontaneous abortions and congenital anomalies have been reported
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)
- GlivecNovartis Europharm Limited · EMEA/H/C/000406
- Imatinib Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/002681
- Imatinib Teva · genericTeva B.V. · EMEA/H/C/002585
Source: European Medicines Agency (EMA), product information
Austria
- ImagerolanG.L. Pharma Gmbh · 1 register entry
- Imatinib1a Pharma Gmbh, Sandoz Gmbh, Grindeks, Hcs Bvba · 6 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- ImanivecTad Pharma Gmbh · 1 register entry
- Imatinib1 A Pharma Gmbh, Ratiopharm Gmbh, Devatis Gmbh, Onkovis Gmbh, Zentiva Pharma Gmbh, Amarox Pharma Gmbh, Aqvida Gmbh, Basics Gmbh, Axionovo Gmbh, Cipla Europe Nv, Hexal Ag, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Denk Pharma Gmbh & Co. Kg, Aliud Pharma Gmbh · 16 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- GlimatineTEPE İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
- GliotinABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- GlitinibNOBEL İLAÇ PAZARLAMA VE SAN. LTD. ŞTİ. · 1 register entry
- GlivecNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 2 register entries
- GlivonNOBEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- ImafenPHARMİNAL MEDİKAL İLAÇ A.Ş. · 1 register entry
- ImaglivSABA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- ImatenilLOGUS İLAÇ SAN.TİC. A.Ş. · 5 register entries
- ImatisDEVA HOLDİNG A.Ş. · 3 register entries
- ImatraTRPHARM İLAÇ SAN. TİC. A.Ş. · 1 register entry
- ImavecKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 2 register entries
- MaxinibCENTURİON İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
Show all 17 brand names
- NibtuONKO İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- NobimatNOBİS SCİENTİFİC İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- PantikorWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- VaglinibDR. SERTUS İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
- YerubaNOBEL SAĞLIK ÜRÜNLERİ LTD ŞTİ · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Imatinib Eg, Imatinib Grindeks, Imatinib Krka D.D., Imatinib Sandoz, Mosyopa
- Bulgaria
- Иматиниб Тева Фарма, Меаксин
- Croatia
- Imakrebin, Meaxin, Plivatinib
- Cyprus
- Imarem, Imatinib Koanaa, Imatinib Remedica, Imatinib Tad, Vianib
- Czechia
- Imanivec, Imatinib Grindeks, Imatinib Krka D.D., Imatinib Sandoz, Imatinib Teva Pharma, Meaxin
- Denmark
- Bimatix, Imatinib "sandoz", Imatinib Amarox, Imatinib Cipla, Imatinib Hexal, Imatinib Krka D.D., Imatinib Stada, Imatinib Viatris, Imatinib Zentiva
- Estonia
- Glipox, Imatinib Grindeks, Imatinib Sandoz, Meaxin
- Finland
- Bimatix, Imatinib Hexal, Imatinib Krka D.D., Imatinib Orion, Imatinib Ratiopharm, Imatinib Sandoz, Imatinib Stada
- France
- Imatinib Arrow Lab, Imatinib Bgr, Imatinib Cristers, Imatinib Eg, Imatinib Grindeks, Imatinib Hcs, Imatinib Sandoz, Imatinib Viatris, Imatinib Zentiva, Imatinib Zydus
- Greece
- Imatek, Imatinib Aenorasis, Imatinib Demo, Imatinib Krka, Imatinib Vocate, Vianib
- Hungary
- Imaniver, Imatinib, Latib, Nibix
- Iceland
- Bimatix, Glivec, Imatinib Accord, Imatinib Krka D.D., Imatinib Teva, Imatinib Viatris
- Ireland
- Imatinib Krka D.D., Imatinib Rowex
- Italy
- Imanivec, Imatinib Dr. Reddy’s, Imatinib Eg Stada, Imatinib Sandoz
- Latvia
- Imatinib Grindeks, Imatinib Inteli, Itivas
- Liechtenstein
- Glivec, Imatinib Accord, Imatinib Teva
- Lithuania
- Glipox, Imatinib Grindeks, Imatinib Inteli, Imatinib Sandoz, Meaxin, Mosyopa
- Luxembourg
- Imatinib
- Malta
- Imatinib Tad, Nibix
- Netherlands
- Bimatix, Imakrebin, Imatinib, Leutipol, Mosyopa
- Norway
- Bimatix, Glivec, Imatinib Accord, Imatinib Krka D.D., Imatinib Sandoz, Imatinib Teva, Imatinib Zentiva
- Poland
- Imatenil, Meaxin, Nibix
- Portugal
- Imatinib Aurobindo, Imatinib Aurovitas, Imatinib Farmoz, Imatinib Krka D.D., Imatinib Normon, Imatinib Viatris, Imatinib Zentiva
- Romania
- Imakrebin, Imatinib Grindeks, Imatinib Stada
- Slovakia
- Imatinib Glenmark, Imatinib Grindeks, Imatinib Sandoz, Imatinib Stada, Meaxin
- Slovenia
- Meaxin
- Spain
- Imatinib Cipla, Imatinib Farmalider, Imatinib Kern Pharma, Imatinib Krka D.D., Imatinib Normon, Imatinib Qilu, Imatinib Sandoz, Imatinib Tarbis
- Sweden
- Bimatix, Imatinib Amarox, Imatinib Cipla, Imatinib Grindeks, Imatinib Hexal, Imatinib Krka D.D., Imatinib Sandoz, Imatinib Stada, Imatinib Viatris, Imatinib Zentiva
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
- European Medicines Agency. Glivec – 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/glivec-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
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.