Review decisions
Showing 610 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00171
… death were: sudden cardiac death, sepsis, shock, and lung cancer. Frequencies of adverse events were comparable …
Product Type: Drug
Control Number: 162761
DIN(s): 02412764, 02412772, 02412799, 02412802, 02412810
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2013-02-25
Issued / Original Publication Date: 2013-12-10
Decision / Authorization Date: 2013-09-19
Updated Date: 2024-07-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00225
… review for Kadcyla related to Tumour Lysis Syndrome (quick cancer cells breakdown severely affecting many organs). NC # … was: the adjuvant treatment of HER2-positive early breast cancer patients who have residual invasive disease following … growth factor receptor 2 (HER2)-positive, metastatic breast cancer who received both prior treatment with Herceptin …
Product Type: Drug
Control Number: 162414
DIN(s): 02412365, 02473224
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2013-02-08
Issued / Original Publication Date: 2013-12-03
Decision / Authorization Date: 2013-09-11
Updated Date: 2023-03-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00219
… was no longer evident, and numerical imbalances in breast cancer cases diminished significantly. However, the non-statistically significant imbalance in bladder cancer cases did not decrease. In light of the lack of a … and the presence of other risk factors in the bladder cancer patients, these imbalances are regarded as a signal …
Product Type: Drug
Control Number: 160877
DIN(s): 02435462, 02435470
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-12-07
Issued / Original Publication Date: 2015-07-06
Decision / Authorization Date: 2014-12-12
Updated Date: 2025-01-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00182
… started a safety review for Duavive related to ovarian cancer in menopausal women (a type of cancer detected in the ovaries). NDS # 160681 2012-12-04 … bleeding. Known, suspected, or past history of breast cancer. Known or suspected estrogen-dependent malignant …
Product Type: Drug
Control Number: 160681
DIN(s): 02432854
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-12-04
Issued / Original Publication Date: 2015-01-21
Decision / Authorization Date: 2014-10-23
Updated Date: 2025-09-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00202
… patients with non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk of … of patients with metastatic castration-sensitive prostate cancer. The submission was reviewed and considered … patients with non-metastatic castration-resistant prostate cancer. The submission was reviewed and considered …
Product Type: Drug
Control Number: 159678
DIN(s): 02407329
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2012-10-26
Issued / Original Publication Date: 2013-07-29
Decision / Authorization Date: 2013-05-29
Updated Date: 2025-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00260
… locally advanced, inflammatory, or early breast cancer (EBC) (either >2 cm in diameter or node positive). … in combination with Perjeta in the authorized early breast cancer and metastatic breast cancer indications. The submission was reviewed and …
Product Type: Drug
Control Number: 158419
DIN(s): 02405016, 02405024
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2012-08-31
Issued / Original Publication Date: 2013-07-10
Decision / Authorization Date: 2013-04-12
Updated Date: 2023-02-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00232
… therapies ( Assessing the potential risk of pancreatic cancer ). New safety review started by Health Canada Not … safety data in this population. Pancreatitis and Pancreatic Cancer In the Phase II/III clinical studies, acute … with regards to a possible increased risk of pancreatic cancer associated with use of the DPP-4 inhibitors and …
Product Type: Drug
Control Number: 158335
DIN(s): 02417189, 02417197, 02417200
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-08-29
Issued / Original Publication Date: 2014-02-10
Decision / Authorization Date: 2013-11-27
Updated Date: 2025-03-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00189
… for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with … for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with … for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with …
Product Type: Drug
Control Number: 157970
DIN(s): 02403390
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2012-08-15
Issued / Original Publication Date: 2013-05-07
Decision / Authorization Date: 2013-03-11
Updated Date: 2026-03-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00228
… naïve) patients with metastic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation. Regulatory … treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation whose disease has … Cutaneous melanoma is the most aggressive form of skin cancer. Systematic treatment options for unresectable or …
Product Type: Drug
Control Number: 157665
DIN(s): 02409623, 02409658, 02539993
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-08-03
Issued / Original Publication Date: 2014-02-13
Decision / Authorization Date: 2013-07-18
Updated Date: 2025-06-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00198
… death were reported as cardiac disorders, followed by lung cancer. Of the 5 cardiovascular deaths, 2 were sudden … death were classed as cardiac disorders, followed by lung cancer. Of the 5 cardiovascular deaths, 2 were sudden …
Product Type: Drug
Control Number: 157598
DIN(s): 02409720
Manufacturer: Almirall, S.A.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-07-31
Issued / Original Publication Date: 2013-09-24
Decision / Authorization Date: 2013-07-29
Updated Date: 2023-09-25