| Asciminib | EU EMA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (Ph+ CML CP). Scemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib (see section 5.1). | approved | Aug 25, 2022 | ema |
| Asciminib | US FDA | — | SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 ) Previously treated Ph+ CML in CP. ( 1 ) Ph+ CML in CP with the T315I mutation. ( 1 )accelerated | approved | Oct 29, 2021 | openfda |
| Asciminib | US FDA | — | SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 ) Previously treated Ph+ CML in CP. ( 1 ) Ph+ CML in CP with the T315I mutation. ( 1 )accelerated | approved | Oct 29, 2021 | openfda |
| Axitinib | CA Health Canada | — | Marketed in Canada as INLYTA (DIN 02389630) under ATC L01EK01 AXITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Aug 17, 2012 | health-canada-dpd |
| Axitinib | CA Health Canada | — | Marketed in Canada as INLYTA (DIN 02389649) under ATC L01EK01 AXITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Aug 17, 2012 | health-canada-dpd |
| Axitinib | CA Health Canada | — | Marketed in Canada as INLYTA (DIN 02422891) under ATC L01EK01 AXITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Mar 31, 2025 | — | health-canada-dpd |
| Axitinib | CA Health Canada | — | Marketed in Canada as INLYTA (DIN 02422883) under ATC L01EK01 AXITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Mar 31, 2025 | — | health-canada-dpd |
| Axitinib | EU EMA | Renal Cell Carcinoma | Axitinib Accord is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. | approved | Sep 19, 2024 | ema |
| Axitinib | EU EMA | Renal Cell Carcinoma | Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. | approved | Sep 3, 2012 | ema |
| Axitinib | US FDA | — | Efficacy supplement 2022-09-22 (see label) | approved | Sep 22, 2022 | openfda |
| Axitinib | US FDA | — | Efficacy supplement 2020-06-04 (see label) | approved | Jun 4, 2020 | openfda |
| Axitinib | US FDA | — | in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. | approved | Jan 27, 2012 | openfda |
| Axitinib | US FDA | Renal Cell Carcinoma | in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). | approved | Jan 27, 2012 | openfda |
| Axitinib | US FDA | Renal Cell Carcinoma | as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. | approved | Jan 27, 2012 | openfda |
| Blinatumomab | EU EMA | Acute Lymphoblastic Leukemia | Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with Philadelphia chromosome-negative CD19 positive B‑cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy (see section 4.2). Blincyto is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor ALL. | approved | Nov 23, 2015 | ema |
| Bosutinib | CA Health Canada | — | Marketed in Canada as REDDY-BOSUTINIB (DIN 02560046) under ATC L01EA04 BOSUTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 8, 2025 | health-canada-dpd |
| Bosutinib | CA Health Canada | — | Marketed in Canada as REDDY-BOSUTINIB (DIN 02560038) under ATC L01EA04 BOSUTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 8, 2025 | health-canada-dpd |
| Bosutinib | CA Health Canada | — | Marketed in Canada as BOSULIF (DIN 02419149) under ATC L01EA04 BOSUTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Apr 24, 2014 | health-canada-dpd |
| Bosutinib | CA Health Canada | — | Marketed in Canada as BOSULIF (DIN 02419157) under ATC L01EA04 BOSUTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Mar 24, 2014 | health-canada-dpd |
| Bosutinib | CA Health Canada | — | Marketed in Canada as REDDY-BOSUTINIB (DIN 02560011) under ATC L01EA04 BOSUTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Bosutinib | CA Health Canada | — | Marketed in Canada as BOSULIF (DIN 02483793) under ATC L01EA04 BOSUTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Mar 31, 2025 | — | health-canada-dpd |
| Bosutinib | EU EMA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Bosulif is indicated for the treatment of:• Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).• Adult and paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.• Adult patients with accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. | approved | Mar 27, 2013 | ema |
| Bosutinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. ( 1 ) | approved | Sep 26, 2023 | openfda |
| Bosutinib | US FDA | — | Efficacy supplement 2023-09-26 (see label) | approved | Sep 26, 2023 | openfda |
| Bosutinib | US FDA | — | Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2) ] . BOSULIF is a kinase inhibitor indicated for the treatment of • adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. ( 1 ) | approved | Sep 26, 2023 | openfda |
| Bosutinib | US FDA | — | Efficacy supplement 2021-05-14 (see label) | approved | May 14, 2021 | openfda |
| Bosutinib | US FDA | — | Efficacy supplement 2017-12-19 (see label) | approved | Dec 19, 2017 | openfda |
| Bosutinib | US FDA | — | Efficacy supplement 2017-04-13 (see label) | approved | Apr 13, 2017 | openfda |
| Bosutinib | US FDA | — | Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2) ] . BOSULIF is a kinase inhibitor indicated for the treatment of • adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. ( 1 ) | approved | Sep 4, 2012 | openfda |
| Bosutinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. ( 1 ) | approved | Sep 4, 2012 | openfda |
| Dasatinib | CA Health Canada | — | Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562502) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 31, 2026 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562464) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 31, 2026 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562480) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 31, 2026 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562472) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 31, 2026 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562499) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 31, 2026 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as TEVA-DASATINIB (DIN 02478315) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 5, 2021 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as TEVA-DASATINIB (DIN 02478323) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 5, 2021 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as TEVA-DASATINIB (DIN 02478358) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 5, 2021 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as TEVA-DASATINIB (DIN 02478331) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 5, 2021 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as TEVA-DASATINIB (DIN 02478307) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 5, 2021 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as TARO-DASATINIB (DIN 02499320) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Mar 4, 2021 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as TARO-DASATINIB (DIN 02499339) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Mar 4, 2021 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as TARO-DASATINIB (DIN 02499282) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Mar 4, 2021 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as TARO-DASATINIB (DIN 02499304) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Mar 4, 2021 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as TARO-DASATINIB (DIN 02499312) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Mar 4, 2021 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as TARO-DASATINIB (DIN 02499347) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Mar 4, 2021 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as APO-DASATINIB (DIN 02481499) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 6, 2020 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as APO-DASATINIB (DIN 02470705) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 6, 2020 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as APO-DASATINIB (DIN 02470713) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 6, 2020 | health-canada-dpd |
| Dasatinib | CA Health Canada | — | Marketed in Canada as APO-DASATINIB (DIN 02470721) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 6, 2020 | health-canada-dpd |