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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
179
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 44 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated yesterdaySource 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 |
|---|---|---|---|---|---|---|---|
| Aug 27, 2020 | Tucatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TUKYSA (DIN 02499835) under ATC L01EH03 TUCATINIB. Indications are not published in the Drug Product Database — see… | DIN02499835 | approvedsource: Marketed | health-canada-dpd |
| Aug 19, 2020 | Cladribine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CLADRIBINE INJECTION (DIN 02494574) under ATC L01BB04 CLADRIBINE. Indications are not published in the Drug Product… | DIN02494574 | approvedsource: Marketed | health-canada-dpd |
| Aug 12, 2020 | Daratumumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as DARZALEX SC (DIN 02502712) under ATC L01FC01 DARATUMUMAB. Indications are not published in the Drug Product Database… | DIN02502712 | approvedsource: Marketed | health-canada-dpd |
| Aug 10, 2020 | Glasdegib | Health Canada CA | cancer not stated in this record | Marketed in Canada as DAURISMO (DIN 02498480) under ATC L01XJ03 GLASDEGIB. Indications are not published in the Drug Product Database — see… | DIN02498480 | approvedsource: Marketed | health-canada-dpd |
| Aug 10, 2020 | Glasdegib | Health Canada CA | cancer not stated in this record | Marketed in Canada as DAURISMO (DIN 02498472) under ATC L01XJ03 GLASDEGIB. Indications are not published in the Drug Product Database — see… | DIN02498472 | approvedsource: Marketed | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 3, 2020 | Isatuximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as SARCLISA (DIN 02498243) under ATC L01FC02 ISATUXIMAB. Indications are not published in the Drug Product Database —… | DIN02498243 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 29, 2020 | Alpelisib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PIQRAY (DIN 02497085) under ATC L01EM03 ALPELISIB. Indications are not published in the Drug Product Database — see… | DIN02497085 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 26, 2020 | Rituximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as RUXIENCE (DIN 02495724) under ATC L01FA01 RITUXIMAB. Indications are not published in the Drug Product Database — see… | DIN02495724 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 27, 2020 | Fulvestrant | Health Canada CA | cancer not stated in this record | Marketed in Canada as FULVESTRANT INJECTION (DIN 02468549) under ATC L02BA03 FULVESTRANT. Indications are not published in the Drug Product… | DIN02468549 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 24, 2020 | Darolutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as NUBEQA (DIN 02496348) under ATC L02BB06 DAROLUTAMIDE. Indications are not published in the Drug Product Database —… | DIN02496348 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 7, 2020 | Pegfilgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as FULPHILA (DIN 02484153) under ATC L03AA13 PEGFILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02484153 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 31, 2020 | Arsenic Trioxide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ARSENIC TRIOXIDE SOLUTION FOR INJECTION (DIN 02487357) under ATC L01XX27 ARSENIC TRIOXIDE. Indications are not… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 20, 2019 | Arsenic Trioxide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ARSENIC TRIOXIDE FOR INJECTION (DIN 02492768) under ATC L01XX27 ARSENIC TRIOXIDE. Indications are not published in… | DIN |
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.
| approvedsource: Marketed |
| health-canada-dpd |
| Jul 3, 2020 | Isatuximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as SARCLISA (DIN 02498235) under ATC L01FC02 ISATUXIMAB. Indications are not published in the Drug Product Database —… | DIN02498235 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Jun 29, 2020 | Alpelisib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PIQRAY (DIN 02497077) under ATC L01EM03 ALPELISIB. Indications are not published in the Drug Product Database — see… | DIN02497077 | approvedsource: Marketed | health-canada-dpd |
| Jun 29, 2020 | Alpelisib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PIQRAY (DIN 02497069) under ATC L01EM03 ALPELISIB. Indications are not published in the Drug Product Database — see… | DIN02497069 | approvedsource: Marketed | health-canada-dpd |
| Jun 23, 2020 | Bortezomib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BORTEZOMIB FOR INJECTION (DIN 02467003) under ATC L01XG01 BORTEZOMIB. Indications are not published in the Drug… | DIN02467003 | approvedsource: Marketed | health-canada-dpd |
| Jun 19, 2020 | Imatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as MINT-IMATINIB (DIN 02492342) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database —… | DIN02492342 | approvedsource: Marketed | health-canada-dpd |
| Jun 19, 2020 | Imatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as MINT-IMATINIB (DIN 02492334) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database —… | DIN02492334 | approvedsource: Marketed | health-canada-dpd |
| Jun 10, 2020 | Filgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as NIVESTYM (DIN 02485656) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02485656 | approvedsource: Marketed | health-canada-dpd |
| Jun 10, 2020 | Filgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as NIVESTYM (DIN 02485591) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02485591 | approvedsource: Marketed | health-canada-dpd |
| Jun 9, 2020 | Olaratumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as LARTRUVO (DIN 02480271) under ATC L01FX10 OLARATUMAB. Indications are not published in the Drug Product Database —… | DIN02480271 | withdrawnsource: Cancelled Post Marketsince Sep 25, 2020 | health-canada-dpd |
| Jun 1, 2020 | Cabazitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as CABAZITAXEL FOR INJECTION (DIN 02495635) under ATC L01CD04 CABAZITAXEL. Indications are not published in the Drug… | DIN02495635 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| May 22, 2020 | Rituximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as RIXIMYO (DIN 02498316) under ATC L01FA01 RITUXIMAB. Indications are not published in the Drug Product Database — see… | DIN02498316 | approvedsource: Marketed | health-canada-dpd |
| May 19, 2020 | Bortezomib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BORTEZOMIB FOR INJECTION (DIN 02493306) under ATC L01XG01 BORTEZOMIB. Indications are not published in the Drug… | DIN02493306 | approvedsource: Marketed | health-canada-dpd |
| May 19, 2020 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as TARO-DOXORUBICIN LIPOSOMAL (DIN 02493020) under ATC L01DB01 DOXORUBICIN. Indications are not published in the Drug… | DIN02493020 | approvedsource: Marketed | health-canada-dpd |
| May 15, 2020 | Pegfilgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZIEXTENZO (DIN 02497395) under ATC L03AA13 PEGFILGRASTIM. Indications are not published in the Drug Product Database… | DIN02497395 | approvedsource: Marketed | health-canada-dpd |
| May 11, 2020 | Filgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as NIVESTYM (DIN 02485583) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02485583 | approvedsource: Marketed | health-canada-dpd |
| May 11, 2020 | Filgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as NIVESTYM (DIN 02485575) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02485575 | approvedsource: Marketed | health-canada-dpd |
| withdrawnsource: Cancelled Post Marketsince Mar 31, 2025 |
| health-canada-dpd |
| Apr 16, 2020 | Trastuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as KANJINTI (DIN 02496690) under ATC L01FD01 TRASTUZUMAB. Indications are not published in the Drug Product Database —… | DIN02496690 | approvedsource: Marketed | health-canada-dpd |
| Apr 16, 2020 | Arsenic Trioxide | Health Canada CA | cancer not stated in this record | Marketed in Canada as TRISENOX (DIN 02480387) under ATC L01XX27 ARSENIC TRIOXIDE. Indications are not published in the Drug Product… | DIN02480387 | withdrawnsource: Cancelled Post Marketsince Apr 18, 2023 | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Mar 11, 2020 | Gemtuzumab Ozogamicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as MYLOTARG (DIN 02494388) under ATC L01FX02 GEMTUZUMAB OZOGAMICIN. Indications are not published in the Drug Product… | DIN02494388 | approvedsource: Marketed | health-canada-dpd |
| Mar 10, 2020 | Entrectinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as ROZLYTREK (DIN 02495007) under ATC L01EX14 ENTRECTINIB. Indications are not published in the Drug Product Database —… | DIN02495007 | approvedsource: Marketed | health-canada-dpd |
| Mar 4, 2020 | Entrectinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as ROZLYTREK (DIN 02495015) under ATC L01EX14 ENTRECTINIB. Indications are not published in the Drug Product Database —… | DIN02495015 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Feb 3, 2020 | Gilteritinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as XOSPATA (DIN 02495058) under ATC L01EX13 GILTERITINIB. Indications are not published in the Drug Product Database —… | DIN02495058 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Jan 9, 2020 | Niraparib | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZEJULA (DIN 02489783) under ATC L01XK02 NIRAPARIB. Indications are not published in the Drug Product Database — see… | DIN02489783 | withdrawnsource: Dormantsince Oct 26, 2024 | health-canada-dpd |
| Jan 6, 2020 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-DASATINIB (DIN 02481502) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database… | DIN02481502 | approvedsource: Marketed | health-canada-dpd |
| Jan 6, 2020 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-DASATINIB (DIN 02481499) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database… | DIN02481499 | approvedsource: Marketed | health-canada-dpd |
| Jan 6, 2020 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-DASATINIB (DIN 02470721) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database… | DIN02470721 | approvedsource: Marketed | health-canada-dpd |
| Jan 6, 2020 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-DASATINIB (DIN 02470713) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database… | DIN02470713 | approvedsource: Marketed | health-canada-dpd |
| Jan 6, 2020 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-DASATINIB (DIN 02470705) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database… | DIN02470705 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Dec 20, 2019 | Neratinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as NERLYNX (DIN 02490536) under ATC L01EH02 NERATINIB. Indications are not published in the Drug Product Database — see… | DIN02490536 | approvedsource: Marketed | health-canada-dpd |
| Dec 18, 2019 | Cabazitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as CABAZITAXEL FOR INJECTION (DIN 02487500) under ATC L01CD04 CABAZITAXEL. Indications are not published in the Drug… | DIN02487500 | approvedsource: Marketed | health-canada-dpd |
| Dec 18, 2019 | Cabazitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as CABAZITAXEL FOR INJECTION (DIN 02487497) under ATC L01CD04 CABAZITAXEL. Indications are not published in the Drug… | DIN02487497 | approvedsource: Marketed | health-canada-dpd |
| Dec 11, 2019 | Trastuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as HERZUMA (DIN 02480794) under ATC L01FD01 TRASTUZUMAB. Indications are not published in the Drug Product Database —… | DIN02480794 | approvedsource: Marketed | health-canada-dpd |
| Dec 11, 2019 | Rituximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as TRUXIMA (DIN 02478390) under ATC L01FA01 RITUXIMAB. Indications are not published in the Drug Product Database — see… | DIN02478390 | approvedsource: Marketed | health-canada-dpd |
| Dec 11, 2019 | Rituximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as TRUXIMA (DIN 02478382) under ATC L01FA01 RITUXIMAB. Indications are not published in the Drug Product Database — see… | DIN02478382 | approvedsource: Marketed | health-canada-dpd |
| Dec 10, 2019 | Lutetium (177lu) Oxodotreotide | Health Canada CA | cancer not stated in this record | Marketed in Canada as LUTATHERA (DIN 02484552) under ATC V10XX04 LUTETIUM (177LU) OXODOTREOTIDE. Indications are not published in the Drug… | DIN02484552 | approvedsource: Marketed | health-canada-dpd |
| Dec 9, 2019 | Erdafitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BALVERSA (DIN 02493233) under ATC L01EN01 ERDAFITINIB. Indications are not published in the Drug Product Database —… | DIN02493233 | approvedsource: Marketed | health-canada-dpd |
| Dec 9, 2019 | Erdafitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BALVERSA (DIN 02493225) under ATC L01EN01 ERDAFITINIB. Indications are not published in the Drug Product Database —… | DIN02493225 | approvedsource: Marketed | health-canada-dpd |