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Regulatory
Every record is one authority's decision for one application or DIN, shown with its jurisdiction, date, indication text as published and status. A molecule approved in one jurisdiction for one indication is not 'approved' in general.
RegulatoryDevelopment pipeline →Methodology
Coverage
Counts of records, not of drugs approved: one application can carry several dated records (original approval, efficacy supplements, one row per DIN in Canada).
Approval records
4,342
Distinct drugs
373
Records naming a cancer
982
Dated in the last 12 months
183
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |
|---|---|---|---|---|---|---|---|
| FDA | US | 2,343 | 304 | 2,343 | 0 | 115 | Sep 18, 2026 |
| Health Canada | CA | 1,538 | 273 | 979 | 559 | 48 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated 14 hours agoSource updated unknown3 authority · jurisdiction pairs ingested
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Latest approval date first; records without a date are listed last. Filters combine.
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 20, 2012 | Zoledronic Acid | EMA EU | cancer not stated in this record | Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced… | centralisedEMEA/H/C/002488 | withdrawnsince Mar 1, 2024 | ema |
| Apr 20, 2012 | Capecitabine | EMA EU | cancer not stated in this record | Capecitabine Accord is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.… | centralisedEMEA/H/C/002386 | approved | ema |
| Apr 20, 2012 | Capecitabine | EMA EU | cancer not stated in this record | Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer.… | centralisedEMEA/H/C/002362 | approved | ema |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 9, 2012 | Mercaptopurine | EMA EU | Acute Lymphoblastic Leukemia | Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children. |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 17, 2012 | Vemurafenib | EMA EU | Melanoma | Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 31, 2012 | Docetaxel | EMA EU | cancer not stated in this record | Treatment of breast cancer, special forms of lung cancer (non-small-cell lung cancer), prostate cancer, gastric cancer, or head and neck… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 22, 2011 | Topotecan | EMA EU | cancer not stated in this record | Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 5, 2011 | Abiraterone | EMA EU | Castration-Resistant Prostate Carcinoma | Zytiga is indicated with prednisone or prednisolone for: the treatment of metastatic castration resistant prostate cancer in adult men who… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 26, 2011 | Ibandronic Acid | EMA EU | cancer not stated in this record | Ibandronic acid Sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 17, 2011 | Eribulin | EMA EU | cancer not stated in this record | Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 21, 2011 | Docetaxel | EMA EU | cancer not stated in this record | Breast cancer Docetaxel Teva Pharma monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 17, 2010 | Ibandronic Acid | EMA EU | cancer not stated in this record | Ibandronic acid 50mg Ibandronic Acid Teva is indicated for the prevention of skeletal events (pathological fractures, bone complications… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 14, 2010 | Pazopanib | EMA EU | cancer not stated in this record | Renal-cell carcinoma (RCC) Votrient is indicated in adults for the first-line treatment of advanced renal-cell carcinoma (RCC) and for… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 26, 2010 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 19, 2010 | Ofatumumab | EMA EU | Chronic Lymphocytic Leukemia | Previously untreated chronic lymphocytic leukaemia (CLL): Arzerra in combination with chlorambucil or bendamustine is indicated for the… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 15, 2010 | Temozolomide | EMA EU | Glioblastoma | For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 28, 2010 | Temozolomide | EMA EU | Glioblastoma | For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 21, 2009 | Topotecan | EMA EU | cancer not stated in this record | Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first line or… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 2, 2009 | Everolimus | EMA EU | Renal Cell Carcinoma | Hormone-receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 30, 2009 | Plerixafor | EMA EU | cancer not stated in this record | Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 24, 2009 | Gefitinib | EMA EU | Lung Non-Small Cell Carcinoma | Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 20, 2009 | Catumaxomab | EMA EU | cancer not stated in this record | Removab is indicated for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 6, 2009 | Mifamurtide | EMA EU | Osteosarcoma | Mepact is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 17, 2009 | Degarelix | EMA EU | Malignant Prostate Neoplasm | FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated: - for treatment of adult male patients with advanced… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 17, 2008 | Azacitidine | EMA EU | cancer not stated in this record | Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT)… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 7, 2008 | Histamine | EMA EU | Acute Myeloid Leukemia | Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 15, 2008 | Filgrastim | EMA EU | cancer not stated in this record | Tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with… |
A record is one authority's decision for one application/DIN; the same molecule appears once per jurisdiction and indication. Health Canada DPD does not publish indications — its records state the brand, DIN and ATC class only, and a cancelled or dormant DIN is the status of one product, not of the molecule. FDA cancer mappings come from label text and are flagged probabilistic on the drug page.
| centralisedEMEA/H/C/002022 |
| approved |
| ema |
| centralisedEMEA/H/C/002409 |
| approved |
| ema |
| Feb 16, 2012 | Vandetanib | EMA EU | Thyroid Gland Medullary Carcinoma | Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally… | centralisedEMEA/H/C/002315 | approved | ema |
| centralisedEMEA/H/C/002317 |
| withdrawnsince Jan 31, 2015 |
| ema |
| centralisedEMEA/H/C/002261 |
| withdrawnsince Oct 2, 2014 |
| ema |
| Dec 13, 2011 | 5-Aminolevulinic Acid | EMA EU | cancer not stated in this record | Treatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2; see section 5.1) and of field… | centralisedEMEA/H/C/002204 | approved | ema |
| centralisedEMEA/H/C/002321 |
| approved |
| ema |
| Sep 2, 2011 | Everolimus | EMA EU | cancer not stated in this record | Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of adult patients with renal… | centralisedEMEA/H/C/002311 | approved | ema |
| centralisedEMEA/H/C/002367 |
| withdrawnsince Jan 9, 2024 |
| ema |
| Jul 13, 2011 | Ipilimumab | EMA EU | cancer not stated in this record | Melanoma Yervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic)… | centralisedEMEA/H/C/002213 | approved | ema |
| Jul 13, 2011 | Temozolomide | EMA EU | Glioblastoma | Temozolomide Sun is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with… | centralisedEMEA/H/C/002198 | approved | ema |
| Jul 13, 2011 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/002173 | approved | ema |
| centralisedEMEA/H/C/002084 |
| approved |
| ema |
| Mar 17, 2011 | Cabazitaxel | EMA EU | Malignant Prostate Neoplasm | Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic… | centralisedEMEA/H/C/002018 | approved | ema |
| Mar 14, 2011 | Tegafur | EMA EU | cancer not stated in this record | Teysuno is indicated in adults: - for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1).… | centralisedEMEA/H/C/001242 | approved | ema |
| centralisedEMEA/H/C/002032 |
| withdrawnsince Jan 21, 2014 |
| ema |
| Jan 21, 2011 | Ibandronic Acid | EMA EU | cancer not stated in this record | Concentrate for solution for infusion Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or… | centralisedEMEA/H/C/002025 | approved | ema |
| Jan 6, 2011 | Topotecan | EMA EU | Cervical Carcinoma | Topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or… | centralisedEMEA/H/C/002282 | approved | ema |
| centralisedEMEA/H/C/001195 |
| approved |
| ema |
| centralisedEMEA/H/C/001141 |
| approved |
| ema |
| Jun 9, 2010 | Topotecan | EMA EU | cancer not stated in this record | Topotecan monotherapy is indicated for the treatment of patients with relapsed small-cell lung cancer (SCLC) for whom re-treatment with the… | centralisedEMEA/H/C/001192 | approved | ema |
| Jun 7, 2010 | Filgrastim | EMA EU | cancer not stated in this record | Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with… | centralisedEMEA/H/C/001142 | approved | ema |
| centralisedEMEA/H/C/001120 |
| approved |
| ema |
| May 10, 2010 | Docetaxel | EMA EU | cancer not stated in this record | Breast cancer Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with… | centralisedEMEA/H/C/001074 | withdrawnsince May 25, 2012 | ema |
| centralisedEMEA/H/C/001131 |
| withdrawnsince Feb 28, 2019 |
| ema |
| centralisedEMEA/H/C/001128 |
| withdrawnsince Sep 15, 2022 |
| ema |
| Mar 15, 2010 | Temozolomide | EMA EU | Glioblastoma | For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as… | centralisedEMEA/H/C/001127 | withdrawn | ema |
| Mar 15, 2010 | Temozolomide | EMA EU | Glioblastoma | For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as… | centralisedEMEA/H/C/001125 | approved | ema |
| Mar 15, 2010 | Thiotepa | EMA EU | cancer not stated in this record | TEPADINA is indicated, in combination with other chemotherapy medicinal products:- with or without total body irradiation (TBI), as… | centralisedEMEA/H/C/001046 | approved | ema |
| centralisedEMEA/H/C/001126 |
| approved |
| ema |
| Jan 26, 2010 | Docetaxel | EMA EU | cancer not stated in this record | Breast cancer Docetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:… | centralisedEMEA/H/C/001107 | withdrawn | ema |
| Jan 25, 2010 | Temozolomide | EMA EU | Glioblastoma | Temomedac hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with… | centralisedEMEA/H/C/001124 | approved | ema |
| centralisedEMEA/H/C/001071 |
| withdrawn |
| ema |
| Sep 21, 2009 | Vinflunine | EMA EU | Urothelial Carcinoma | Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the… | centralisedEMEA/H/C/000983 | approved | ema |
| centralisedEMEA/H/C/001038 |
| approved |
| ema |
| centralisedEMEA/H/C/001030 |
| approved |
| ema |
| Jul 24, 2009 | Topotecan | EMA EU | cancer not stated in this record | Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the… | centralisedEMEA/H/C/001031 | withdrawnsince Jan 15, 2019 | ema |
| centralisedEMEA/H/C/001016 |
| approved |
| ema |
| centralisedEMEA/H/C/000972 |
| withdrawnsince Jun 2, 2017 |
| ema |
| centralisedEMEA/H/C/000802 |
| approved |
| ema |
| centralisedEMEA/H/C/000986 |
| approved |
| ema |
| Feb 6, 2009 | Filgrastim | EMA EU | cancer not stated in this record | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic… | centralisedEMEA/H/C/000918 | approved | ema |
| Feb 6, 2009 | Filgrastim | EMA EU | cancer not stated in this record | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic… | centralisedEMEA/H/C/000917 | approved | ema |
| centralisedEMEA/H/C/000978 |
| approved |
| ema |
| centralisedEMEA/H/C/000796 |
| approved |
| ema |
| centralisedEMEA/H/C/000827 |
| approved |
| ema |
| Sep 15, 2008 | Filgrastim | EMA EU | cancer not stated in this record | Biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with… | centralisedEMEA/H/C/000826 | withdrawnsince Sep 23, 2015 | ema |