| Imatinib Mesylate | US FDA | — | Efficacy supplement 2006-10-19 (see label) | approved | Oct 19, 2006 | openfda |
| Imatinib Mesylate | US FDA | — | Efficacy supplement 2006-10-19 (see label) | approved | Oct 19, 2006 | openfda |
| Imatinib Mesylate | US FDA | — | Efficacy supplement 2006-10-19 (see label) | approved | Oct 19, 2006 | openfda |
| Imatinib Mesylate | US FDA | — | Efficacy supplement 2006-10-19 (see label) | approved | Oct 19, 2006 | openfda |
| Imatinib Mesylate | US FDA | — | Efficacy supplement 2006-09-27 (see label) | approved | Sep 27, 2006 | openfda |
| Imatinib Mesylate | US FDA | — | Efficacy supplement 2005-10-20 (see label) | approved | Oct 20, 2005 | openfda |
| Imatinib Mesylate | US FDA | — | Efficacy supplement 2005-03-14 (see label) | approved | Mar 14, 2005 | openfda |
| Imatinib Mesylate | US FDA | — | Efficacy supplement 2003-12-08 (see label) | approved | Dec 8, 2003 | openfda |
| Imatinib Mesylate | US FDA | — | Efficacy supplement 2003-05-20 (see label) | approved | May 20, 2003 | openfda |
| Imatinib Mesylate | US FDA | Chronic Eosinophilic Leukemia, Not Otherwise Specified | Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. | approved | Apr 18, 2003 | openfda |
| Imatinib Mesylate | US FDA | Aggressive Systemic Mastocytosis | Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. | approved | Apr 18, 2003 | openfda |
| Imatinib Mesylate | US FDA | Myelodysplastic/Myeloproliferative Neoplasm | Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. | approved | Apr 18, 2003 | openfda |
| Imatinib Mesylate | US FDA | Acute Lymphoblastic Leukemia | Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). | approved | Apr 18, 2003 | openfda |
| Imatinib Mesylate | US FDA | Malignant Gastrointestinal Stromal Tumor | Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). | approved | Apr 18, 2003 | openfda |
| Imatinib Mesylate | US FDA | Acute Lymphoblastic Leukemia | Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. | approved | Apr 18, 2003 | openfda |
| Imatinib Mesylate | US FDA | — | Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. • Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. • Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). • Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. | approved | Apr 18, 2003 | openfda |
| Inotuzumab Ozogamicin | EU EMA | Acute Lymphoblastic Leukemia | Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult pPatients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). Besponsa is indicated as monotherapy for paediatric patients 1 year and older with CD22-positive B cell precursor ALL: in first relapse after allo-haematopoietic stem cell transplant (HSCT); after any first relapse in patients with Very High Risk (VHR) disease (see section 5.1); after a second or greater relapse; and in those with refractory disease. Patients with Philadelphia chromosome positive (Ph+) disease should have exhausted relevant BCR-ABL targeting treatment options. | approved | Jun 28, 2017 | ema |
| Interferon Alfa-2b | EU EMA | — | Chronic hepatitis B Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis-B viral replication (presence of DNA of hepatitis-B virus (HBV-DNA) and hepatitis-B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and / or fibrosis. Chronic hepatitis C Before initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon. Adult patients IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for hepatitis-C virus-RNA (HCV-RNA). The best way to use IntronA in this indication is in combination with ribavirin. Children three years of age and older and adolescents IntronA is indicated, in a combination regimen with ribavirin, for the treatment of children three years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that resulted in reduced final adult height in some patients. The decision to treat should be made on a case-by-case basis. Hairy-cell leukaemia Treatment of patients with hairy cell leukaemia. Chronic myelogenous leukaemia Monotherapy Treatment of adult patients with Philadelphia-chromosome- or bcr/abl-translocation-positive chronic myelogenous leukaemia. Clinical experience indicates that a haematological and cytogenetic major / minor response is obtainable in the majority of patients treated. A major cytogenetic response is defined by < 34 % Ph+ leukaemic cells in the bone marrow, whereas a minor response is ? 34 %, but < 90 % Ph+ cells in the marrow. Combination therapy The combination of interferon alfa-2b and cytarabine (Ara-C) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy. Multiple myeloma As maintenance therapy in patients who have achieved objective remission (more than 50% reduction in myeloma protein) following initial induction chemotherapy. Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated. Follicular lymphoma Treatment of high-tumour-burden follicular lymphoma as adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen. High tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10 %, pyrexia > 38°C for more than eight days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia. Carcinoid tumour Treatment of carcinoid tumours with lymph node or liver metastases and with 'carcinoid syndrome'. Malignant melanoma As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g. patients with primary or recurrent (clinical or pathological) lymph-node. |
| Nilotinib | CA Health Canada | — | Marketed in Canada as REDDY-NILOTINIB (DIN 02556634) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Apr 24, 2025 | health-canada-dpd |
| Nilotinib | CA Health Canada | — | Marketed in Canada as REDDY-NILOTINIB (DIN 02556642) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Apr 24, 2025 | health-canada-dpd |
| Nilotinib | CA Health Canada | — | Marketed in Canada as APO-NILOTINIB (DIN 02550903) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Feb 13, 2025 | health-canada-dpd |
| Nilotinib | CA Health Canada | — | Marketed in Canada as APO-NILOTINIB (DIN 02550881) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Feb 13, 2025 | health-canada-dpd |
| Nilotinib | CA Health Canada | — | Marketed in Canada as TASIGNA (DIN 02481715) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Oct 4, 2023 | May 17, 2019 | health-canada-dpd |
| Nilotinib | CA Health Canada | — | Marketed in Canada as TASIGNA (DIN 02368250) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 15, 2011 | health-canada-dpd |
| Nilotinib | CA Health Canada | — | Marketed in Canada as TASIGNA (DIN 02315874) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 30, 2008 | health-canada-dpd |
| Nilotinib | CA Health Canada | — | Marketed in Canada as REDDY-NILOTINIB (DIN 02556626) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Nilotinib | CA Health Canada | — | Marketed in Canada as PMS-NILOTINIB (DIN 02565005) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Nilotinib | CA Health Canada | — | Marketed in Canada as PMS-NILOTINIB (DIN 02564947) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Nilotinib | EU EMA | Chronic Myeloid Leukemia, Philadelphia Chromosome Positive, BCR-ABL1 Positive | Nilotinib Accord is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. | approved | Aug 22, 2024 | ema |
| Nilotinib | EU EMA | Chronic Myeloid Leukemia, Philadelphia Chromosome Positive, BCR-ABL1 Positive | Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib. Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. | approved | Nov 19, 2007 | ema |
| Nilotinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. | approved | May 29, 2026 | openfda |
| Nilotinib | US FDA | — | Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. | approved | May 29, 2026 | openfda |
| Nilotinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. | approved | Feb 19, 2025 | openfda |
| Nilotinib | US FDA | — | Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. | approved | Feb 19, 2025 | openfda |
| Nilotinib | US FDA | — | Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. | approved | Nov 7, 2024 | openfda |
| Nilotinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. | approved | Nov 7, 2024 | openfda |
| Nilotinib | US FDA | — | Efficacy supplement 2021-09-23 (see label) | approved | Sep 23, 2021 | openfda |
| Nilotinib | US FDA | — | Efficacy supplement 2021-09-23 (see label) | approved | Sep 23, 2021 | openfda |
| Nilotinib | US FDA | — | Efficacy supplement 2018-03-22 (see label) | approved | Mar 22, 2018 | openfda |
| Nilotinib | US FDA | — | Efficacy supplement 2017-12-22 (see label) | approved | Dec 22, 2017 | openfda |
| Nilotinib | US FDA | — | Efficacy supplement 2015-01-27 (see label) | approved | Jan 27, 2015 | openfda |
| Nilotinib | US FDA | — | Efficacy supplement 2014-01-22 (see label) | approved | Jan 22, 2014 | openfda |
| Nilotinib | US FDA | — | Efficacy supplement 2012-12-20 (see label) | approved | Dec 20, 2012 | openfda |
| Nilotinib | US FDA | — | Efficacy supplement 2011-11-18 (see label) | approved | Nov 18, 2011 | openfda |
| Nilotinib | US FDA | — | Efficacy supplement 2011-01-14 (see label) | approved | Jan 14, 2011 | openfda |
| Nilotinib | US FDA | — | Efficacy supplement 2010-06-17 (see label) | approved | Jun 17, 2010 | openfda |
| Nilotinib | US FDA | — | Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. | approved | Oct 29, 2007 | openfda |
| Nilotinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. | approved | Oct 29, 2007 | openfda |
| Nilotinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. | approved | Oct 29, 2007 | openfda |
| Ponatinib | CA Health Canada | — | Marketed in Canada as ICLUSIG (DIN 02437341) under ATC L01EA05 PONATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Dormantsince Aug 8, 2022 | Jan 7, 2016 | health-canada-dpd |