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Inofficial Register of CML Tyrosine Kinase Inhibitors
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(Last Update: 22 Jul 2014). Please note this is a purely patient-driven, non-commercial initiative. It has no interest to promote, or assess, any of the drugs. The only intent is to increase transparency in a confusing environment. It is not complete or correct, and will potentially never be. Therefore, your contribution with additional or corrected data is essential! We look forward to receiving your updates on approval status, availability of new and known generics in your country, and on products newly approved by your local competent authorities, at info@cmladvocates.net
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N/D = No data availableN/A = Not applicableMA = Market Authorization
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Medicine NameTypeActive SubstanceManufacturer or Marketing Authorisation HolderAvailability & Authorisation-StatusPublicly available documentation (1/3)Publicly available documentation (2/3)Publicly available documentation (3/3)Authorisation dateIndication
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Glivec or GleevecOriginator (patented)imatinibNovartis Europharm Ltd.Authorised by EMA (EMEA/H/C/000406), FDA, many other countries
See EMA-website
07/11/2001 (EMA)Ph-/BCR-ABL-positive CML in all phases
Ph+ALL
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Imatinib AccordGenericimatinibAccord Healthcare LtdAuthorised by EMA (EMEA/H/C/002681) for all EU-countries + Norway + Iceland, FDA, many other countriesSee EMA-website01/07/2013 (EMA)Ph-/BCR-ABL-positive CML (only adult blast-phase, and pediatric)
Ph+ALL
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Imatinib ActavisGenericimatinib mesilateActavis Group PTC ehfAuthorised by EMA (EMEA/H/C/002594) for all EU-countries + Norway + IcelandSee EMA-website17/04/2013 (EMA)Ph-/BCR-ABL-positive CML (only adult blast-phase, and pediatric)

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Imatinib TevaGenericimatinibTeva Pharma B.V.Authorised by EMA (EMEA/H/C/002585) for all EU-countries + Norway + IcelandSee EMA-website08/01/2013 (EMA)Ph-/BCR-ABL-positive CML (only adult blast-phase, and pediatric)

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VeenatGenericimatinibNatCo, IndiaDrug available in India, China, Costa Rica, Hong Kong.
Europe: MA granted in Bulgaria, Estonia, Latvia, Lithuania, Poland, Romania, Slovakia (Decentralised Procedure)
Formal authorization: Documentation available in India. No documentation available in other countries (source: cmladvocates survey).
CML
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Imatinib medacGenericimatinibMedac Gesellschaft fuer Spezialpraeparaten mbH, Germany / Pabianickie Zakłady Farmaceutyczne Polfa S.A., PolandAuthorised by EMA (EMEA/H/C/002692)See EMA-website25/09/2013 (EMA)Children with chronic myeloid leukaemia (CML)
Adults with Ph+ CML in blast crisis
Adults with Ph+ acute lymphoblastic leukaemia (ALL)
Adults with myelodysplastic or myeloproliferative diseases (MDS/MPD)
Adults with advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL)
Adults with dermatofibrosarcoma protuberans (DFSP)
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TasignaOriginator (patented)nilotinibNovartis Europharm Ltd.Authorised by EMA (EMEA/H/C/000798), FDA, many other countriesSee EMA-website19/11/2007 (EMA)Ph-/BCR-ABL-positive CML
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SprycelOriginator (patented)dasatinibBristol-Myers Squibb Pharma EEIGAuthorised by EMA (EMEA/H/C/000709), FDA, many other countriesSee EMA-website20/11/2006 (EMA)Ph-/BCR-ABL-positive CML
Ph+ALL
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BosulifOriginator (patented)bosutinib (as monohydrate)Pfizer LtdAuthorised by EMA (EMEA/H/C/002373), FDA, few other countriesSee EMA-website27/03/2013 (EMA)Adult patients with chronic-phase, accelerated-phaseand blast-phase, Ph-/BCR-ABL-positive CML previously treated with one or more tyrosine kinase inhibitors and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
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IclusigOriginator (patented)ponatinibAriad Pharma LtdAuthorised by EMA (EMEA/H/C/002695), FDA, few other countriesSee EMA-website01/07/2013 (EMA)CML patients with dasatinib or nilotinib resistance, dasatinib or nilotinib intolerance or T315I mutation.
Ph+ ALL patients with dasatinib resistance, dasatinib intolerance or T315I mutation.
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GenfatinibGenericimatinibLaboratorio Teva-Tuteur, ArgentinaDrug available in Russia
Formal authorization: N/D
EMA-Authorization: none
Bioequivalence Report for downloadCML
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Philachromin or Philachromin-fsGenericimatinibDrug available in Russia
Formal authorization: N/D
EMA-Authorization: none
Manufacturer's instructions for downloadCML
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GlimatinibGenericimatinibBenta Pharma Industries, LebanonDrug available in Lebanon
Formal authorization: no (source: cmladvocates survey)
EMA-Authorization: none
CML
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ImatibGenericimatinib mesylateCipla, IndiaDrug available in India, Argentina, Costa Rica, Guatemala, Dominican Republic, Egypt
Formal authorization: ANMAT (Argentina) reg. #55561. India: N/D. Other countries: no documentation available or N/D (source: cmladvocates survey)
EMA-Authorization: none
Information pamphlet ANMAT, Argentina, Reg. no. 55561
CML
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AnzovipGenericimatinibWatson ActavisDrug available in Serbia
Formal authorization: yes
Documentation not made available to the public (source: cmladvocates survey)
EMA-Authorization: none
CML
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KimatinibGenericimatinibLaboratorios Clausen, UruguayDrug available in Uruguay
Formal authorization: N/D
EMA-Authorization: none
CML
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ImatinGenericimatinibLibra, PolandDrug available in Uruguay
Formal authorization: N/D
EMA-Authorization: none
CML
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PlivatinibGenericimatinibDrug available in Bosnia-Herzegowina
Formal authorization: N/D
EMA-Authorization: none
CML
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GlipoxGenericimatinibAdamed, PolandDrug available in Lithuania
Formal authorization: application-process ongoing (source: cmladvocates survey)
EMA-Authorization: none
CML
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YlerisGenericimatinibKrka, SloveniaDrug available in Lithuania
Formal authorization: application-process ongoing (source: cmladvocates survey)
EMA-Authorization: none
CML
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ImicapGenericimatinibFK, IndiaDrug available in Nepal
Formal authorization: N/D
EMA-Authorization: none
CML
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CelonibGenericimatinibCelon Labs, IndiaDrug available in Nigeria, India
Formal authorization: N/D
EMA-Authorization: none
CML
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ImmutinGenericimatinibNobel Pharma, KazakhstanDrug available in Kazakhstan
Formal authorization: yes
(source: cmladvocates survey)
EMA-Authorization: none
CML
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LeutinibGenericimatinibDrug available in Colombia
Formal authorization: yes
Documentation not made available to the public (source: cmladvocates survey)
EMA-Authorization: none
CML
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MatibGenericimatinibDrug available in Colombia
Formal authorization: yes
Documentation not made available to the public (source: cmladvocates survey)
EMA-Authorization: none
CML
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ImalakGenericimatinibSun Pharma, IndiaDrug available in India
Formal authorization: Yes. Documentation available (source: cmladvocates survey)
EMA-Authorization: none
CML
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DasanatGenericdasatinibNatCo, IndiaDrug available in India
Formal authorization: Yes. Documentation available (source: cmladvocates survey)
EMA-Authorization: none
CML
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LitedaGenericdasatinibRAFFO S.A. , ArgentinaDrug available in Argentina, Dominican Republic, Costa Rica & Guatemala
Formal authorization: N/D
EMA-Authorization: none
ANMAT (Argentina): reg.# 55457
LeafletBrand registered in Chile, Argentina, Colombia and MexicoInformation pamphlet ANMAT, ArgentinaCML
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FlumatinibGenericimatinibJiangsu Haoseng PharmacyDrug in clinical trials in ChinaCML
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Ge Ni KGenericimatinibJiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.Drug available in China, approved by China Food and Drug Administration (patent no: CN201210281256.5)Pharmacy´s websiteJuly 2013CML
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VativioGenericimatinibNovartisGenerica drug (4 x 100mg capsules) available in South Africa. Half price compared to original Gleevec.
Formal authorization: N/D
Documentation available: N/D
EMA-Authorization: none
CML
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ImatenilGenericimatinibLogus İlaç San. Tic.Ltd.Şti.Drug available in Turkeyhttp://logusilac.com.tr/Default.aspx11.02.2013Ph-/BCR-ABL-positive CML in all phases Ph+ALL
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ImatisGenericimatinibDeva Holding A.ŞDrug available in Turkeyhttp://www.deva.com.tr/12.03.2012Ph-/BCR-ABL-positive CML
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ImavecGenericimatinibKoçak Farma İlaç ve Kimya Sanayi A.Ş.Drug available in Turkeyhttp://www.kocakfarma.com/tr/Default.aspx22.11.2012Ph-/BCR-ABL-positive CML
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ImaglivGenericimatinibSaba İlaç Sanayi ve Ticaret A.Ş.Drug available in Turkeyhttp://www.sabailac.com.tr/tr/index.php21.05.2013Ph-/BCR-ABL-positive CML
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Celonib 400Genericimatinib mesilateCelon Labs, IndiaAuthorized by Philippine Food and Drug Administration, Certificate of Product
Registration (CPR) valid until 21.02.2018

Drug available in India
Formal authorization: N/D
Expiry 21.02.2018CML
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APO-IMATINIBGenericimatinib mesilate as alpha crystal formulationApotex, CanadaAuthorized by Health Canada on April 2, 2013; In most provinces in Canada, Pharmacists are authorized (indeed, required!) to switch a CML patient from
branded imatinib mesylate to the generic formulation. One exception is in the province of
Quebec; physicians can write ‘do not substitute’ on prescriptions that they order. This must be written in the
doctor’s own hand on the actual prescription.

Europe: MA granted in Belgium, Estonia, Latvia, Netherlands,
Lithuania (Decentralised Procedure);
Product Monograph02/04/2013 (Health Canada)CML, not indicated for GIST
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TEVA-IMATINIBGenericimatinib mesilate as alpha crystal formulationTeva, IsraelAuthorized by Health Canada on April 2, 2013; In most provinces in Canada, Pharmacists are authorized (indeed, required!) to switch a CML patient from
branded imatinib mesylate to the generic formulation. One exception is in the province of
Quebec; physicians can write ‘do not substitute’ on prescriptions that they order. This must be written in the
doctor’s own hand on the actual prescription.
Product Monograph02/04/2013 (Health Canada)CML, not indicated for GIST
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Imarem®GenericimatinibPharos / Remedica, CyprusEurope: MA granted for Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Hungary, Iceland, Latvia, Lithuania, Netherlands, Poland, Romania, Slovakia, Slovenia (Decentralised Procedure / National Registration Procedure); 2013 in Cyprus (according to manufacturer´s information: http://www.remedica.eu/aboutus/history)CML
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Imatinib Synthon (100mg)GenericimatinibSynthon, The NetherlandsEurope: MA granted in Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Iceland, Latvia, Lithuania, Malta, Netherlands, Romania, Slovakia, Slovenia (Decentralised Procedure)
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IMANIB 100 mg, IMANIB 400 mgGenericimatinib mesylateIntas, IndiaEurope: MA granted in Bulgaria, Croatia, Czech Republic, Estonia, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia (Decentralised Procedure)
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Imatinib Nobilus EntGenericimatinib mesylateNobilus, PolandEurope: MA granted in Poland (Decentralised Procedure)SPC - Summary of Product Characteristics, 100 mg - Polish only!SPC - Summary of Product Characteristics, 400 mg - Polish only!CML
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IMATENILGenericimatinibBiofarm, PolandEurope: MA granted in Poland, Romania (Decentralised
Procedure)
SPC - Summary of Product Characteristics, 100 mg - Polish only!SPC - Summary of Product Characteristics, 400 mg - Polish only!CML
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KinacelGenericimatinibCelon, PolandEurope: MA granted in Poland (National Registration Procedure)SPC - Summary of Product Characteristics, 100 mg - Polish only!SPC - Summary of Product Characteristics, 400 mg - Polish only!CML
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Imatinib GlindeksGenericimatinib mesylateGrindeks, LatviaEurope: MA granted in Estonia, Latvia, Lithuania, Sweden (Decentralised Procedure)Public Assessment Report Imatinib Glindeks hard capsules, 100 mgCML
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AgacelGenericimatinib mesylateTuteur S.A.C.I.F.I.AArgentina: Authorized by ANMAT, certificate number 54979Information pamphletCML, Ph+ALL, Myelodyaplastic Syndrome, ASM, HES, GIST, DFSP
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ClinidGenericimatinib mesylateBioprofarma S.A.Argentina: Authorized by ANMAT, certificate number 57195Information pamphletCML, Ph+ALL, Myelodyaplastic Syndrome, ASM, HES, GIST, DFSP
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DaturGenericimatinib mesylateLaboratorio Internacional Argentino, S.A.Argentina: Authorized by ANMAT, certificate number 57115
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Imatinib EriochemGenericimatinib mesylateEriochem, S.A.Argentina: Authorized by ANMAT, certificate number 57120Information pamphletCML, Ph+ALL, Myelodyaplastic Syndrome, ASM, HES, GIST, DFSP
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Imatinib KemexGenericimatinib mesylateLaboratorio Kemex, S.A.Argentina: Authorized by ANMAT, certificate number 57255
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IngerinibGenericimatinib mesylateIngerics, S.A.Argentina: Authorized by ANMAT, certificate number 57116Information pamphletCML, GIST
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MesinibGenericimatinib mesylateLaboratorio Varifarma, S.A.Argentina: Authorized by ANMAT, certificate number 55095Information pamphletCML, GIST
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TagonibGenericimatinib mesylateMicrosules Argentina, S.A. de S.C.I.I.A.Argentina: Authorized by ANMAT, certificate number 53186Information pamphletCML, GIST
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TimabGenericimatinib mesylateLaboratorio LKM, S.A.Argentina: Authorized by ANMAT, certificate number 53657
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UtinibGenericimatinib mesylateLafedar, S.A.Argentina: Authorized by ANMAT, certificate number 57128Information pamphletCML, Ph+ALL, Myelodyaplastic Syndrome, ASM, HES, GIST, DFSP
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VekGenericimatinib mesylateLaboratorio Dosa, S.A.Argentina: Authorized by ANMAT, certificate number 56377Information pamphletChange of nameCML
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ZiatirGenericimatinib mesylateLaboratorios Richmond, S.A.C.I.F.Argentina: Authorized by ANMAT, certificate number 52987Information pamphletCML, Ph+ALL, Myelodyaplastic Syndrome, ASM, HES, GIST, DFSP
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DasonibGenericdasatinibMicrosules Argentina, S.A. de S.C.I.I.A.Argentina: Authorized by ANMAT, certificate number 56756Information pamphletCML, Ph+ALL
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DasteribGenericdasatinibTuteur S.A.C.I.F.I.AArgentina: Authorized by ANMAT, certificate number 57218Information pamphlet
CML, Ph+ALL
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FontraxGenericdasatinibLaboratorios Richmond, S.A.C.I.F.Argentina: Authorized by ANMAT, certificate number 55922Information pamphletCML, Ph+ALL
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RembreGenericdasatinibLaboratorio LKM, S.A.Argentina: Authorized by ANMAT, certificate number 57007Information pamphletCML, Ph+ALL
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SprytinibGenericdasatinibLaboratorio Dosa, S.A.Argentina: Authorized by ANMAT, certificate number 56468Information pamphletChange of nameCML, Ph+ALL
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UltracellGenericdasatinibLafedar, S.A.Argentina: Authorized by ANMAT, certificate number 56867Information pamphletCML, Ph+ALL
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ZeiteGenericimatinib mesylateRecalcineDrug available in Peru and Ecuador
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KadirGenericimatinib mesylateLaboratorio RiderChile: Approved by ISPCH
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ImatinibGenericimatinib mesylateLaboratorio Euromed ChileChile: Approved by ISPCH
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BIOTINIB 400MGGenericimatinibCipla LTD. (India) Colombia: approved by INVIMA, reg.no.: 2011M-0011970 3/14/2011 (INVIMA)
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Lupitib 400 mgGenericimatinibLupin Laboratories (India)Drug available in India
Formal authorization: N/D
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Mesylonib 100 mgGenericimatinibMiracalus Pharma Pvt LtdDrug available in India
Formal authorization: N/D
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Mesylonib 400 mgGenericimatinibMiracalus Pharma Pvt LtdDrug available in India
Formal authorization: N/D
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Mitinab 100 mgGenericimatinibGlenmark Pharmaceuticals Ltd.Drug available in India
Formal authorization: N/D
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Mitinab 400 mgGenericimatinibGlenmark Pharmaceuticals Ltd.Drug available in India
Formal authorization: N/D
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Resimat 100 mgGenericimatinibResonance Laboratories Pvt.LtdDrug available in India
Formal authorization: N/D
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Resimat 400 mgGenericimatinibResonance Laboratories Pvt.LtdDrug available in India
Formal authorization: N/D
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Shantinib 100 mg capsule
GenericimatinibShantha Biotechnics Pvt LtdDrug available in India
Formal authorization: N/D
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Zoleta 100 mg capsule
GenericimatinibRanbaxy Laboratories Ltd.,Drug available in India
Formal authorization: N/D
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EtersaGenericdasatinibDrug available in Colombia
Formal authorization: N/D
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