| Gemcitabine | CA Health Canada | — | Marketed in Canada as ACT GEMCITABINE (DIN 02436205) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Apr 27, 2020 | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as ACT GEMCITABINE (DIN 02436191) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Apr 27, 2020 | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02412101) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02412071) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION USP (DIN 02409933) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION USP (DIN 02409925) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | 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 |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE INJECTION (DIN 02455382) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | 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 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 AJ-GEMCITABINE (DIN 02409062) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Nov 3, 2015 | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as AJ-GEMCITABINE (DIN 02409054) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Nov 3, 2015 | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02402858) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Jan 12, 2022 | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02402866) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Jan 12, 2022 | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02407299) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince May 8, 2017 | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as GEMCITABINE INJECTION (DIN 02565641) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Gemcitabine | CA Health Canada | — | Marketed in Canada as AJ-GEMCITABINE (DIN 02409070) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Nov 3, 2015 | — | health-canada-dpd |
| Gemcitabine | US FDA | Non-Muscle Invasive Bladder Carcinoma | INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 ) | approved | Sep 9, 2025 | openfda |
| Gemcitabine | US FDA | Malignant Ovarian Neoplasm | in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. | approved | Jun 27, 2025 | openfda |
| Gemcitabine | US FDA | Malignant Breast Neoplasm | in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. | approved | Jun 27, 2025 | openfda |
| Gemcitabine | US FDA | Lung Non-Small Cell Carcinoma | in combination with cisplatin, for the treatment of non-small cell lung cancer. | approved | Jun 27, 2025 | openfda |
| Gemcitabine | US FDA | Malignant Pancreatic Neoplasm | as a single agent for the treatment of pancreatic cancer. | approved | Jun 27, 2025 | openfda |
| Gemcitabine | US FDA | Malignant Pancreatic Neoplasm | as a single agent for the treatment of pancreatic cancer. | approved | Aug 3, 2017 | openfda |
| Gemcitabine | US FDA | Malignant Ovarian Neoplasm | in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. | approved | Aug 3, 2017 | openfda |
| Gemcitabine | US FDA | Malignant Breast Neoplasm | in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. | approved | Aug 3, 2017 | openfda |
| Gemcitabine | US FDA | Lung Non-Small Cell Carcinoma | in combination with cisplatin for the treatment of non-small cell lung cancer. | approved | Aug 3, 2017 | openfda |
| Gemcitabine | US FDA | Lung Non-Small Cell Carcinoma | in combination with cisplatin for the treatment of non-small cell lung cancer. | approved | Aug 4, 2011 | openfda |
| Gemcitabine | US FDA | Malignant Ovarian Neoplasm | in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. | approved | Aug 4, 2011 | openfda |
| Gemcitabine | US FDA | Malignant Breast Neoplasm | in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. | approved | Aug 4, 2011 | openfda |
| Gemcitabine | US FDA | Malignant Pancreatic Neoplasm | as a single agent for the treatment of pancreatic cancer. | approved | Aug 4, 2011 | openfda |
| Mitomycin | CA Health Canada | — | Marketed in Canada as MITOMYCIN FOR INJECTION, USP (DIN 02531941) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Feb 27, 2023 | health-canada-dpd |
| Mitomycin | CA Health Canada | — | Marketed in Canada as MITOMYCIN FOR INJECTION USP (DIN 02464691) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Apr 30, 2018 | health-canada-dpd |
| Mitomycin | CA Health Canada | — | Marketed in Canada as MITOMYCIN FOR INJECTION USP (DIN 02237745) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Feb 28, 2020 | Jul 15, 1998 | health-canada-dpd |
| Mitomycin | CA Health Canada | — | Marketed in Canada as MITOMYCIN FOR INJECTION USP (DIN 02230729) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Feb 28, 2020 | Mar 12, 1998 | health-canada-dpd |
| Mitomycin | CA Health Canada | — | Marketed in Canada as MITOMYCIN FOR INJECTION (DIN 02230451) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Oct 22, 1997 | health-canada-dpd |
| Mitomycin | CA Health Canada | — | Marketed in Canada as MITOMYCIN FOR INJECTION (DIN 02230450) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Feb 10, 2017 | Oct 22, 1997 | health-canada-dpd |
| Mitomycin | CA Health Canada | — | Marketed in Canada as MUTAMYCIN INJ 20MG/VIAL (DIN 00587710) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince May 29, 2006 | Dec 31, 1984 | health-canada-dpd |
| Mitomycin | CA Health Canada | — | Marketed in Canada as MUTAMYCIN INJ 5MG/VIAL (DIN 00381799) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince May 29, 2006 | Dec 31, 1977 | health-canada-dpd |
| Mitomycin | CA Health Canada | — | Marketed in Canada as MITOMYCIN FOR INJECTION (DIN 02557762) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Mitomycin | US FDA | Non-Muscle Invasive Bladder Carcinoma | ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ( 1 ) | approved | Jun 12, 2025 | openfda |
| Mitomycin | US FDA | — | JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). ( 1 ) | approved | Apr 15, 2020 | openfda |
| Mitomycin | US FDA | — | Mitosol ® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery. Mitosol ® is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. ( 1 ) | approved | Feb 7, 2012 | openfda |
| Niraparib | CA Health Canada | — | Marketed in Canada as ZEJULA (DIN 02530031) under ATC L01XK02 NIRAPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 13, 2023 | health-canada-dpd |
| Niraparib | CA Health Canada | — | Marketed in Canada as AKEEGA (DIN 02538563) under ATC L01XK52 NIRAPARIB AND ABIRATERONE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Aug 14, 2023 | health-canada-dpd |
| Niraparib | CA Health Canada | — | Marketed in Canada as AKEEGA (DIN 02538555) under ATC L01XK52 NIRAPARIB AND ABIRATERONE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Aug 14, 2023 | health-canada-dpd |
| Niraparib | CA Health Canada | — | Marketed in Canada as ZEJULA (DIN 02489783) under ATC L01XK02 NIRAPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Dormantsince Oct 26, 2024 | Jan 9, 2020 | health-canada-dpd |
| Niraparib | EU EMA | Malignant Prostate Neoplasm | Treatment of adult patients with prostate cancer. | approved | Apr 19, 2023 | ema |
| Niraparib | EU EMA | Malignant Peritoneal Neoplasm | Zejula is indicated: as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. | approved | Nov 16, 2017 | ema |
| Niraparib | US FDA | — | Efficacy supplement 2025-06-18 (see label) | approved | Jun 18, 2025 | openfda |