Review decisions
Showing 10 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1775582460008
… cisplatin resistance in DDP‑resistant human lung cancer cells via modulation of the nuclear factor‑κB … damage accumulation and P-glycoprotein inhibition in breast cancer cells. Sci Rep 15, 30814 (2025). …
Issued / Original Publication Date: 2026-04-09
Updated Date: 2026-04-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1774530206353
… for sale in Canada for the treatment of specific types of cancer of the blood and bone marrow (acute lymphoblastic … SOS, such as the use of other medications as part of the cancer treatment and underlying medical conditions that are … leukemia managed with N-acetyl Cysteine. Pediatric Blood & Cancer . 2011;57(4):700. doi: …
DIN(s): 02530406
Issued / Original Publication Date: 2026-03-31
Updated Date: 2026-03-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774272110553
… (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). After review of the submission, Health … (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without … Why was the decision issued? Non-muscle-invasive bladder cancer (NMIBC) accounts for roughly 75% of newly diagnosed …
Product Type: Drug
Control Number: 295688
DIN(s): 02566680
Manufacturer: Ferring Inc
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2025-03-04
Decision / Authorization Date: 2026-03-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774274878641
… (tumours ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor … Stage II, IIIA, or IIIB (T3-4 N2) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor … with resectable Stage IIA-IIIB[N2] non-small cell lung cancer (NSCLC). The AEGEAN trial met its two pre-specified …
Product Type: Drug
Control Number: 281503
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-14
Decision / Authorization Date: 2026-02-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1770998522580
… for sale in Canada to treat adults with multiple myeloma (cancer that forms in a type of white blood cell called a … lymphoma (an aggressive type of non-Hodgkin lymphoma, a cancer that affects a type of white blood cells called B …
DIN(s): 02262452, 02423405, 02438399, 02452456, 02456176, 02466708, 02467003, 02467011, 02480255, 02480263, 02485257, 02493306, 02494922, 02494930, 02497433, 02499061, 02503352, 02511932, 02521814, 02536773, 02541777, 02547287, 02550075
Issued / Original Publication Date: 2026-02-20
Updated Date: 2026-02-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1771857891846
… IIA (>4 cm) to IIIB (T3N2 or T4N2) non-small cell lung cancer (NSCLC). The trial demonstrated statistically …
Product Type: Drug
Control Number: 282961
DIN(s): 02446626, 02446634
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-01-19
Decision / Authorization Date: 2026-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770907424396
… locally advanced or metastatic HER2-positive biliary tract cancer (BTC). After review, the indication recommended for … advanced or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as monotherapy. Marketing authorization with …
Product Type: Drug
Control Number: 296499
DIN(s): 02564610
Manufacturer: Jazz Pharmaceuticals Ireland Limited
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2025-04-04
Decision / Authorization Date: 2026-01-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770819331315
… patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. This is an … (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer who are candidates for systemic therapy to include … proficient (MMRp)/microsatellite stable (MSS) endometrial cancer (EC). No changes are proposed for the dosage regimen. …
Product Type: Drug
Control Number: 286361
DIN(s): 02523434
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-26
Decision / Authorization Date: 2025-04-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770827270935
… II to IVA according to the American Joint Committee on Cancer [AJCC], 8th edition). Patients were randomized (1:1) …
Product Type: Drug
Control Number: 299521
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2025-06-30
Decision / Authorization Date: 2026-01-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770915388549
… with treatment-naïve metastatic non-small cell lung cancer (NSCLC). The descriptive analysis of the clinical …
Product Type: Drug
Control Number: 295692
DIN(s): 02565382
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-02-28
Decision / Authorization Date: 2026-02-03