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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 18 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 |
|---|---|---|---|---|---|---|---|
| Jun 19, 2015 | Nivolumab | EMA EU | cancer not stated in this record | Melanoma Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic)… | centralisedEMEA/H/C/003985 | approved | ema |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 28, 2015 | Lenvatinib | EMA EU | cancer not stated in this record | Lenvima is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic,… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 13, 2015 | Pegfilgrastim | EMA EU | cancer not stated in this record | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 14, 2015 | Nintedanib | EMA EU | cancer not stated in this record | Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF). | centralisedEMEA/H/C/003821 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 19, 2014 | Ramucirumab | EMA EU | cancer not stated in this record | Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 21, 2014 | Nintedanib | EMA EU | Lung Non-Small Cell Carcinoma | Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 21, 2014 | Ibrutinib | EMA EU | cancer not stated in this record | Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 22, 2014 | Busulfan | EMA EU | cancer not stated in this record | Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 22, 2014 | Obinutuzumab | EMA EU | cancer not stated in this record | Chronic lymphocytic leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 30, 2014 | Trametinib | EMA EU | cancer not stated in this record | Melanoma Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 21, 2014 | Cabozantinib | EMA EU | Thyroid Gland Medullary Carcinoma | Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma. |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 16, 2014 | 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… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 15, 2013 | Trastuzumab Emtansine | EMA EU | Malignant Breast Neoplasm | Early Breast Cancer (EBC) Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 18, 2013 | Filgrastim | EMA EU | cancer not stated in this record | Grastofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 25, 2013 | Imatinib | EMA EU | cancer not stated in this record | Imatinib medac is indicated for the treatment of: paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+)… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 26, 2013 | Dabrafenib | EMA EU | cancer not stated in this record | Melanoma Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 12, 2013 | Vismodegib | EMA EU | Basal Cell Carcinoma | Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 30, 2013 | Imatinib | EMA EU | cancer not stated in this record | Imatinib Accord is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl)… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 17, 2013 | Imatinib | EMA EU | cancer not stated in this record | Imatinib Actavis is indicated for the treatment of: paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 27, 2013 | Bosutinib | EMA EU | 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… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 1, 2013 | Aflibercept | EMA EU | Malignant Colorectal Neoplasm | Treatment of metastatic colorectal cancer (MCRC). | centralisedEMEA/H/C/002532 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 7, 2013 | Imatinib | EMA EU | cancer not stated in this record | Imatinib Teva is indicated for the treatment of Adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr?abl)… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 19, 2012 | Capecitabine | EMA EU | cancer not stated in this record | Capecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 25, 2012 | Brentuximab Vedotin | EMA EU | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Hodgkin lymphomaAdcetris is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 20, 2012 | Decitabine | EMA EU | Secondary Acute Myeloid Leukemia | Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 23, 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… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 22, 2012 | Docetaxel | EMA EU | cancer not stated in this record | Breast cancer Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 20, 2012 | Capecitabine | EMA EU | cancer not stated in this record | Ecansya is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Ecansya is… |
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/003727 |
| approved |
| ema |
| May 6, 2015 | Ceritinib | EMA EU | cancer not stated in this record | Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer… | centralisedEMEA/H/C/003819 | approved | ema |
| centralisedEMEA/H/C/003910 |
| withdrawnsince Sep 28, 2017 |
| ema |
| approved |
| ema |
| centralisedEMEA/H/C/002829 |
| approved |
| ema |
| Dec 16, 2014 | Olaparib | EMA EU | cancer not stated in this record | Ovarian cancer Lynparza is indicated as monotherapy for the: maintenance treatment of adult patients with advanced (FIGO stages III and IV)… | centralisedEMEA/H/C/003726 | approved | ema |
| centralisedEMEA/H/C/002569 |
| approved |
| ema |
| centralisedEMEA/H/C/003791 |
| approved |
| ema |
| centralisedEMEA/H/C/002806 |
| approved |
| ema |
| Sep 18, 2014 | Idelalisib | EMA EU | cancer not stated in this record | Zydelig is indicated in combination with an anti?CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients… | centralisedEMEA/H/C/003843 | approved | ema |
| Sep 17, 2014 | Filgrastim | EMA EU | cancer not stated in this record | Accofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with… | centralisedEMEA/H/C/003956 | approved | ema |
| centralisedEMEA/H/C/002799 |
| approved |
| ema |
| centralisedEMEA/H/C/002643 |
| approved |
| ema |
| centralisedEMEA/H/C/002640 |
| approved |
| ema |
| centralisedEMEA/H/C/002667 |
| approved |
| ema |
| centralisedEMEA/H/C/002389 |
| approved |
| ema |
| Nov 13, 2013 | Radium Ra223 dichloride | EMA EU | Castration-Resistant Prostate Carcinoma | Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known… | centralisedEMEA/H/C/002653 | approved | ema |
| centralisedEMEA/H/C/002150 |
| withdrawnsince Jan 13, 2025 |
| ema |
| centralisedEMEA/H/C/002692 |
| withdrawnsince Feb 14, 2019 |
| ema |
| Sep 25, 2013 | Afatinib | EMA EU | Lung Non-Small Cell Carcinoma | Giotrif as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally… | centralisedEMEA/H/C/002280 | approved | ema |
| Sep 6, 2013 | Autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor | EMA EU | Malignant Prostate Neoplasm | Provenge is indicated for treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate-resistant prostate cancer… | centralisedEMEA/H/C/002513 | withdrawnsince May 6, 2015 | ema |
| centralisedEMEA/H/C/002604 |
| approved |
| ema |
| Aug 26, 2013 | Regorafenib | EMA EU | cancer not stated in this record | Stivarga is indicated as monotherapy for the treatment of adult patients with: metastatic colorectal cancer (CRC) who have been previously… | centralisedEMEA/H/C/002573 | approved | ema |
| Aug 5, 2013 | Pomalidomide | EMA EU | Multiple Myeloma | Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have… | centralisedEMEA/H/C/002682 | approved | ema |
| centralisedEMEA/H/C/002602 |
| approved |
| ema |
| Jul 1, 2013 | Ponatinib | EMA EU | cancer not stated in this record | Iclusig is indicated as monotherapy in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML)… | centralisedEMEA/H/C/002695 | approved | ema |
| centralisedEMEA/H/C/002681 |
| approved |
| ema |
| Jun 21, 2013 | Enzalutamide | EMA EU | Castration-Resistant Prostate Carcinoma | Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk… | centralisedEMEA/H/C/002639 | approved | ema |
| Jun 21, 2013 | Capecitabine | EMA EU | cancer not stated in this record | Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine… | centralisedEMEA/H/C/002050 | withdrawnsince Jun 21, 2021 | ema |
| centralisedEMEA/H/C/002594 |
| withdrawn |
| ema |
| centralisedEMEA/H/C/002373 |
| approved |
| ema |
| Mar 4, 2013 | Pertuzumab | EMA EU | Early Stage Breast Carcinoma | Metastatic Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive… | centralisedEMEA/H/C/002547 | approved | ema |
| ema |
| centralisedEMEA/H/C/002585 |
| approved |
| ema |
| centralisedEMEA/H/C/002568 |
| approved |
| ema |
| Nov 19, 2012 | Zoledronic Acid | EMA EU | cancer not stated in this record | 4 mg / 5 ml and 4 mg / 100 ml: Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to… | centralisedEMEA/H/C/002365 | withdrawnsince Feb 22, 2024 | ema |
| Nov 18, 2012 | Ibandronic Acid | EMA EU | cancer not stated in this record | Ibandronic acid is indicated in adults for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy… | centralisedEMEA/H/C/002638 | approved | ema |
| centralisedEMEA/H/C/002455 |
| approved |
| ema |
| Oct 23, 2012 | Crizotinib | EMA EU | cancer not stated in this record | Xalkori as monotherapy is indicated for: The first line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non… | centralisedEMEA/H/C/002489 | approved | ema |
| centralisedEMEA/H/C/002221 |
| approved |
| ema |
| Sep 3, 2012 | Axitinib | EMA EU | Renal Cell Carcinoma | Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with… | centralisedEMEA/H/C/002406 | approved | ema |
| centralisedEMEA/H/C/002482 |
| approved |
| ema |
| Aug 23, 2012 | Ruxolitinib | EMA EU | cancer not stated in this record | Myelofibrosis (MF)Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary… | centralisedEMEA/H/C/002464 | approved | ema |
| Aug 16, 2012 | Zoledronic Acid | EMA EU | cancer not stated in this record | Prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia. | centralisedEMEA/H/C/002439 | approved | ema |
| Aug 3, 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/002359 | withdrawnsince Mar 13, 2026 | ema |
| centralisedEMEA/H/C/002539 |
| approved |
| ema |
| May 22, 2012 | Docetaxel | EMA EU | cancer not stated in this record | Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:… | centralisedEMEA/H/C/002325 | approved | ema |
| May 10, 2012 | Pixantrone Dimaleate | EMA EU | B-Cell Malignant Neoplasm | Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell… | centralisedEMEA/H/C/002055 | withdrawnsince Jun 12, 2024 | ema |
| centralisedEMEA/H/C/002605 |
| approved |
| ema |