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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 11 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 |
|---|---|---|---|---|---|---|---|
| Sep 15, 2008 | Filgrastim | EMA EU | cancer not stated in this record | Ratiograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated… | centralisedEMEA/H/C/000825 | approved | ema |
| Sep 15, 2008 | Filgrastim | EMA EU | cancer not stated in this record | Filgrastim ratiopharm is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients… | centralisedEMEA/H/C/000824 | withdrawnsince Apr 20, 2011 | ema |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 10, 2008 | Lapatinib | EMA EU | Malignant Breast Neoplasm | Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2): in combination with… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 16, 2008 | Thalidomide | EMA EU | Multiple Myeloma | Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 11, 2008 | Paclitaxel | EMA EU | cancer not stated in this record | Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 3, 2007 | Panitumumab | EMA EU | Malignant Colorectal Neoplasm | Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): in first-line in… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 19, 2007 | Temsirolimus | EMA EU | cancer not stated in this record | Renal-cell carcinoma Torisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 17, 2007 | Trabectedin | EMA EU | cancer not stated in this record | Yondelis is indicated for the treatment of patients with advanced soft-tissue sarcoma, after failure of anthracyclines and ifosfamide, or… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 22, 2007 | Nelarabine | EMA EU | cancer not stated in this record | Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 29, 2007 | Hydroxycarbamide | EMA EU | cancer not stated in this record | Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 20, 2007 | Docetaxel | EMA EU | cancer not stated in this record | Breast cancer Docetaxel Winthrop 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 |
|---|---|---|---|---|---|---|---|
| Nov 20, 2006 | Dasatinib | EMA EU | cancer not stated in this record | Sprycel is indicated for the treatment of paediatric patients with: newly diagnosed Philadelphia chromosome-positive chronic myelogenous… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 19, 2006 | Sorafenib | EMA EU | cancer not stated in this record | Hepatocellular carcinoma Nexavar is indicated for the treatment of hepatocellular carcinoma. Renal cell carcinoma Nexavar is indicated for… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 29, 2006 | Clofarabine | EMA EU | Acute Lymphoblastic Leukemia | Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 19, 2005 | Erlotinib | EMA EU | cancer not stated in this record | Non-small cell lung cancer (NSCLC) Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 12, 2005 | Bevacizumab | EMA EU | cancer not stated in this record | Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 15, 2004 | Anagrelide | EMA EU | cancer not stated in this record | Xagrid is indicated for the reduction of elevated platelet counts in at-risk essential-thrombocythaemia (ET) patients who are intolerant to… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 22, 2004 | Cinacalcet | EMA EU | cancer not stated in this record | Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Mimpara… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 20, 2004 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesothelioma Alimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 29, 2004 | Cetuximab | EMA EU | cancer not stated in this record | Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 28, 2004 | Mitotane | EMA EU | Adrenal Cortical Carcinoma | Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 25, 2004 | Porfimer | EMA EU | cancer not stated in this record | Photodynamic therapy (PDT) with PhotoBarr is indicated for: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 16, 2004 | Ibritumomab Tiuxetan | EMA EU | Follicular Lymphoma | Zevalin is indicated in adults. [90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 17, 2003 | Celecoxib | EMA EU | cancer not stated in this record | Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 9, 2003 | Busulfan | EMA EU | cancer not stated in this record | Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 22, 2002 | Pegfilgrastim | EMA EU | cancer not stated in this record | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 5, 2002 | Arsenic Trioxide | EMA EU | Acute Promyelocytic Leukemia | Trisenox is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 7, 2001 | Imatinib | EMA EU | cancer not stated in this record | Glivec is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia-chromosome (bcr-abl)-positive… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 24, 2001 | Temoporfin | EMA EU | Head and Neck Squamous Cell Carcinoma | Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 11, 2001 | Cytarabine | EMA EU | Meningeal Lymphoma | Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 29, 2001 | Bexarotene | EMA EU | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 2, 2001 | Capecitabine | EMA EU | cancer not stated in this record | Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer. Xeloda is… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 11, 2000 | Alitretinoin | EMA EU | AIDS-Related Kaposi Sarcoma | Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with acquired-immune-deficiency-syndrome… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 28, 2000 | Trastuzumab | EMA EU | cancer not stated in this record | Breast cancer Metastatic breast cancer Herceptin is indicated for the treatment of patients with HER2-positive metastatic breast cancer: as… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 13, 2000 | Doxorubicin | EMA EU | Malignant Breast Neoplasm | Myocet liposomal, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 9, 2000 | Interferon Alfa-2b | EMA EU | cancer not stated in this record | Chronic hepatitis B Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis-B viral replication… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 19, 1999 | Paclitaxel | EMA EU | cancer not stated in this record | Paxene is indicated for the treatment of patients with: advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 26, 1999 | Temozolomide | EMA EU | Glioblastoma | Temodal hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly 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/000795 |
| approved |
| ema |
| centralisedEMEA/H/C/000823 |
| approved |
| ema |
| centralisedEMEA/H/C/000778 |
| approved |
| ema |
| centralisedEMEA/H/C/000741 |
| approved |
| ema |
| centralisedEMEA/H/C/000799 |
| approved |
| ema |
| Nov 19, 2007 | Nilotinib | EMA EU | Chronic Myeloid Leukemia, Philadelphia Chromosome Positive, BCR-ABL1 Positive | Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic… | centralisedEMEA/H/C/000798 | approved | ema |
| centralisedEMEA/H/C/000773 |
| approved |
| ema |
| Sep 7, 2007 | 5-Aminolevulinic Acid | EMA EU | cancer not stated in this record | Gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (World Health Organization… | centralisedEMEA/H/C/000744 | approved | ema |
| centralisedEMEA/H/C/000752 |
| approved |
| ema |
| centralisedEMEA/H/C/000689 |
| approved |
| ema |
| Jun 14, 2007 | Lenalidomide | EMA EU | cancer not stated in this record | Multiple myeloma Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma… | centralisedEMEA/H/C/000717 | approved | ema |
| centralisedEMEA/H/C/000808 |
| withdrawn |
| ema |
| centralisedEMEA/H/C/000709 |
| approved |
| ema |
| centralisedEMEA/H/C/000690 |
| approved |
| ema |
| Jul 19, 2006 | Sunitinib | EMA EU | cancer not stated in this record | Gastrointestinal stromal tumour (GIST) Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal… | centralisedEMEA/H/C/000687 | approved | ema |
| centralisedEMEA/H/C/000613 |
| approved |
| ema |
| centralisedEMEA/H/C/000618 |
| approved |
| ema |
| centralisedEMEA/H/C/000582 |
| approved |
| ema |
| centralisedEMEA/H/C/000480 |
| approved |
| ema |
| centralisedEMEA/H/C/000575 |
| withdrawnsince Dec 5, 2008 |
| ema |
| Oct 22, 2004 | Cinacalcet | EMA EU | Parathyroid Carcinoma | Secondary hyperparathyroidism Adults Treatment of secondary hyperparathyroidism (HPT) in adult patients with end stage renal disease (ESRD)… | centralisedEMEA/H/C/000570 | withdrawnsince Dec 18, 2025 | ema |
| centralisedEMEA/H/C/000564 |
| approved |
| ema |
| centralisedEMEA/H/C/000558 |
| approved |
| ema |
| centralisedEMEA/H/C/000521 |
| approved |
| ema |
| Apr 26, 2004 | Bortezomib | EMA EU | cancer not stated in this record | Velcade as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult… | centralisedEMEA/H/C/000539 | approved | ema |
| Apr 14, 2004 | Cladribine | EMA EU | Hairy Cell Leukemia | Litak is indicated for the treatment of hairy-cell leukaemia. | centralisedEMEA/H/C/000504 | approved | ema |
| centralisedEMEA/H/C/000493 |
| withdrawnsince Apr 20, 2012 |
| ema |
| Mar 9, 2004 | Fulvestrant | EMA EU | Malignant Breast Neoplasm | Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in… | centralisedEMEA/H/C/000540 | approved | ema |
| centralisedEMEA/H/C/000547 |
| withdrawnsince Jan 4, 2024 |
| ema |
| centralisedEMEA/H/C/000466 |
| withdrawnsince Nov 28, 2008 |
| ema |
| centralisedEMEA/H/C/000472 |
| withdrawn |
| ema |
| centralisedEMEA/H/C/000422 |
| withdrawnsince Dec 5, 2008 |
| ema |
| Aug 22, 2002 | Pegfilgrastim | EMA EU | cancer not stated in this record | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for… | centralisedEMEA/H/C/000420 | approved | ema |
| centralisedEMEA/H/C/000388 |
| approved |
| ema |
| centralisedEMEA/H/C/000406 |
| approved |
| ema |
| centralisedEMEA/H/C/000318 |
| approved |
| ema |
| centralisedEMEA/H/C/000317 |
| withdrawn |
| ema |
| Jul 6, 2001 | Alemtuzumab | EMA EU | Chronic Lymphocytic Leukemia | MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination… | centralisedEMEA/H/C/000353 | withdrawnsince Aug 8, 2012 | ema |
| centralisedEMEA/H/C/000326 |
| approved |
| ema |
| Mar 20, 2001 | 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/000336 | approved | ema |
| centralisedEMEA/H/C/000316 |
| approved |
| ema |
| centralisedEMEA/H/C/000279 |
| withdrawn |
| ema |
| centralisedEMEA/H/C/000278 |
| approved |
| ema |
| centralisedEMEA/H/C/000297 |
| approved |
| ema |
| centralisedEMEA/H/C/000281 |
| withdrawn |
| ema |
| Mar 9, 2000 | Thyrotropin Alfa | EMA EU | Differentiated Thyroid Gland Carcinoma | Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid… | centralisedEMEA/H/C/000220 | approved | ema |
| centralisedEMEA/H/C/000216 |
| withdrawnsince Mar 1, 2010 |
| ema |
| centralisedEMEA/H/C/000229 |
| approved |
| ema |