Review decisions
Showing 460 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00269
… for the treatment of metastatic non-small cell lung cancer as monotherapy, in adults whose tumours have high …
Product Type: Drug
Control Number: 198839
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-10-03
Decision / Authorization Date: 2017-07-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00164
… is authorized for sale in Canada to treat and control non-cancerous enlargement of the gland that makes semen in males … is authorized for sale in Canada to treat and control non-cancerous enlargement of the prostate gland (benign …
Issued / Original Publication Date: 2017-06-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00419
… remodeling, drug resistance, and metastatic progression of cancer. Cabozantinib was evaluated for its inhibitory … was originally developed as a treatment for thyroid cancer; several studies included in this submission were … also observed in mouse xenograft models of human thyroid cancer, lung cancer and breast cancer, as well as in a rat …
Product Type: Drug
Control Number: 206230
DIN(s): 02480824, 02480832, 02480840
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-06-06
Issued / Original Publication Date: 2019-02-12
Decision / Authorization Date: 2018-09-14
Updated Date: 2025-07-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00456
… progestin-dependent malignant neoplasia (e.g. endometrial cancer); endometrial hyperplasia; known, suspected, or past history of breast cancer (Tibella increased the risk of breast cancer recurrence in placebo-controlled trials); undiagnosed …
Product Type: Drug
Control Number: 206099
DIN(s): 02488361
Manufacturer: Biosyent Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-06-01
Issued / Original Publication Date: 2020-01-07
Decision / Authorization Date: 2019-05-10
Updated Date: 2025-03-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00389
… for the treatment of adult patients with metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction, … the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not … the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not …
Product Type: Drug
Control Number: 205852
DIN(s): 02472104, 02472112
Manufacturer: Taiho Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-05-30
Issued / Original Publication Date: 2018-04-06
Decision / Authorization Date: 2018-01-25
Updated Date: 2023-08-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00261
… 2 (HER2)-negative locally advanced or metastatic breast cancer whose disease progressed after prior endocrine … 2 (HER2)-negative locally advanced or metastatic breast cancer whose disease progressed after prior endocrine … HER2-negative locally advanced or metastatic breast cancer whose disease progressed after prior endocrine …
Product Type: Drug
Control Number: 195948
Manufacturer: Pfizer Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-06-14
Decision / Authorization Date: 2017-05-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00266
… the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation. Why was the … for previously treated metastatic non-small cell lung cancer patients with a BRAFV600 mutation were evaluated in a …
Product Type: Drug
Control Number: 199382
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2016-10-18
Decision / Authorization Date: 2017-05-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00267
… the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation. Why was the … for previously treated metastatic non-small cell lung cancer patients with a BRAFV600 mutation were evaluated in a …
Product Type: Drug
Control Number: 199381
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2016-10-18
Decision / Authorization Date: 2017-05-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00256
… for the treatment of recurrent or metastatic squamous cell cancer of the head and neck after platinum-based therapy in … for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or … Patients with recurrent or metastatic squamous cell cancer of the head and neck have poor prognosis. The sponsor …
Product Type: Drug
Control Number: 199379
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2016-10-18
Decision / Authorization Date: 2017-05-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00160
… for sale in Canada to treat specific types of advanced lung cancers. Health Canada reviewed the potential risk of … for sale in Canada to treat specific types of advanced lung cancer. Crizotinib has been marketed in Canada since 2012 … if crizotinib use caused the side effect. The advanced lung cancer itself may have also played a role. While some other …
Issued / Original Publication Date: 2017-05-04