| Cisplatin | CA Health Canada | — | Marketed in Canada as CISPLATIN INJECTION BP (DIN 02536285) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Feb 23, 2024 | health-canada-dpd |
| Cisplatin | CA Health Canada | — | Marketed in Canada as CISPLATIN INJECTION (DIN 02403188) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Aug 29, 2013 | health-canada-dpd |
| Cisplatin | CA Health Canada | — | Marketed in Canada as CISPLATIN INJECTION, MYLAN STD. (DIN 02396890) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jul 6, 2016 | Jun 12, 2013 | health-canada-dpd |
| Cisplatin | CA Health Canada | — | Marketed in Canada as CISPLATIN INJECTION, BP (DIN 02355183) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Apr 10, 2012 | health-canada-dpd |
| Cisplatin | CA Health Canada | — | Marketed in Canada as CISPLATIN INJECTION BP (DIN 02366711) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jul 25, 2022 | Sep 29, 2011 | health-canada-dpd |
| Cisplatin | CA Health Canada | — | Marketed in Canada as CISPLATIN INJECTION BP (DIN 02126613) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 9, 1997 | health-canada-dpd |
| Cisplatin | CA Health Canada | — | Marketed in Canada as PLATINOL AQ INJ 1MG/ML (DIN 00788740) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jul 30, 2001 | Dec 31, 1988 | health-canada-dpd |
| Cisplatin | CA Health Canada | — | Marketed in Canada as CISPLATIN INJ 1MG/ML (DIN 00692743) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Aug 13, 1998 | Dec 31, 1986 | health-canada-dpd |
| Cisplatin | CA Health Canada | — | Marketed in Canada as CISPLATIN INJ 0.5MG/ML (DIN 00644293) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Sep 10, 1996 | Dec 31, 1985 | health-canada-dpd |
| Cisplatin | CA Health Canada | — | Marketed in Canada as CISPLATIN INJECTION (DIN 02422034) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Cisplatin | CA Health Canada | — | Marketed in Canada as PMS-CISPLATIN (DIN 02409194) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Aug 3, 2017 | — | health-canada-dpd |
| Cisplatin | CA Health Canada | — | Marketed in Canada as CISPLATIN INJECTION (DIN 02393832) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Cisplatin | CA Health Canada | — | Marketed in Canada as CISPLATIN INJECTION (DIN 02409186) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Cisplatin | US FDA | — | Efficacy supplement 1993-04-22 (see label) | approved | Apr 22, 1993 | openfda |
| Cisplatin | US FDA | — | Efficacy supplement 1981-12-29 (see label) | approved | Dec 29, 1981 | openfda |
| Cisplatin | US FDA | Malignant Bladder Neoplasm | INDICATIONS Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Cisplatin Injection and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin Injection therapy. Advanced Bladder Cancer Cisplatin Injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy. | approved | Dec 19, 1978 | openfda |
| Erdafitinib | CA Health Canada | — | Marketed in Canada as BALVERSA (DIN 02493233) under ATC L01EN01 ERDAFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 9, 2019 | health-canada-dpd |
| Erdafitinib | CA Health Canada | — | Marketed in Canada as BALVERSA (DIN 02493225) under ATC L01EN01 ERDAFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 9, 2019 | health-canada-dpd |
| Erdafitinib | CA Health Canada | — | Marketed in Canada as BALVERSA (DIN 02493217) under ATC L01EN01 ERDAFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 9, 2019 | health-canada-dpd |
| Erdafitinib | CA Health Canada | — | Marketed in Canada as BALVERSA (DIN 02493241) under ATC L01EN01 ERDAFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Erdafitinib | EU EMA | Urothelial Carcinoma | Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting (see section 5.1). | approved | Aug 22, 2024 | ema |
| Erdafitinib | US FDA | — | Efficacy supplement 2024-01-19 (see label) | approved | Jan 19, 2024 | openfda |
| Erdafitinib | US FDA | — | Efficacy supplement 2024-01-19 (see label) | approved | Jan 19, 2024 | openfda |
| Erdafitinib | US FDA | Urothelial Carcinoma | BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA [see Dosage and Administration (2.1) and Clinical Studies (14.1) ] . BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA. ( 1 , 2.1 ) Limitations of Use BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. ( 1 , 14.1 ) Limitations of Use BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy [see Clinical Studies (14.1) ] . | approved | Apr 12, 2019 | openfda |
| Futibatinib | EU EMA | Cholangiocarcinoma | Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.conditional | approved | Jul 4, 2023 | ema |
| Futibatinib | US FDA | Intrahepatic Cholangiocarcinoma | LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). LYTGOBI is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )accelerated | approved | Sep 30, 2022 | openfda |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as ACT GEMCITABINE (DIN 02433117) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Aug 13, 2019 | May 2, 2016 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02407310) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince May 8, 2017 | Jun 26, 2014 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02407302) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince May 8, 2017 | Jun 26, 2014 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION CONCENTRATE (DIN 02423510) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Aug 7, 2017 | Apr 17, 2014 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE INJECTION (DIN 02412292) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 24, 2013 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE SUN FOR INJECTION (DIN 02373173) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Dec 19, 2024 | Mar 21, 2013 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE SUN FOR INJECTION (DIN 02373181) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Dec 19, 2024 | Mar 21, 2013 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE INJECTION (DIN 02402831) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Mar 20, 2013 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02324202) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jan 17, 2020 | Aug 31, 2011 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02370034) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Oct 28, 2025 | Aug 31, 2011 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02318741) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Aug 1, 2018 | Oct 1, 2009 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02324210) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Oct 28, 2025 | Jul 16, 2009 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02305526) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Apr 30, 2018 | Sep 10, 2008 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02305534) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Apr 30, 2018 | Jun 27, 2008 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02298775) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Aug 1, 2018 | Jan 25, 2008 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02298783) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Aug 1, 2014 | Dec 27, 2007 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE HYDROCHLORIDE FOR INJECTION (DIN 02302101) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Aug 1, 2019 | Nov 20, 2007 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE HYDROCHLORIDE FOR INJECTION (DIN 02302098) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Aug 1, 2019 | Nov 20, 2007 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMZAR (200MG/VIAL) (DIN 02230308) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Mar 11, 2015 | Mar 10, 1997 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMZAR (1GM/VIAL) (DIN 02230309) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Nov 1, 2015 | Mar 10, 1997 | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02437163) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Jul 13, 2022 | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02437171) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Jul 13, 2022 | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02437155) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Jul 13, 2022 | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02412098) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |