Review decisions
Showing 530 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00318
… (Assessing the potential risk of new or returning liver cancer named hepatocellular carcinoma). Summary Safety … for Zepatier related to hepatocellular carcinoma (liver cancer). NC # 204225 2017-03-29 Issued NOL 2017-06-29 … to early recurrence of hepatocellular carcinoma (liver cancer) and hepatitis B reactivation. NC # 193658 2016-03-22 …
Product Type: Drug
Control Number: 185866
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-03-15
Updated Date: 2022-11-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00290
Product Type: Drug
Control Number: 184479
DIN(s): 02451034
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-03-15
Updated Date: 2011-11-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00079
… Imatinib is a drug authorized for sale in Canada to treat cancer (chemotherapy). It is used to treat several solid tumours or blood cancers. Health Canada reviewed the potential risk of tendon … to a bone. Use in Canada Imatinib belongs to a class of cancer drugs called tyrosine kinase inhibitors. It is used …
Issued / Original Publication Date: 2016-03-07
Updated Date: 2018-06-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00081
… Bcr-Abl tyrosine kinase inhibitors are used to treat blood cancers. The potential for these drugs to cause harm to the … in Canada. These drugs are taken orally to treat blood cancers. Gleevec is also used to treat some solid tumours. …
Issued / Original Publication Date: 2016-03-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00096
… with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based … in patients with metastatic squamous non-small cell lung cancer (SQ NSCLC) who had experienced disease progression … patients with metastatic non-squamous non-small lung cell cancer (NSQ NSCLC) who had experienced disease progression …
Product Type: Drug
Control Number: 186625
DIN(s): 02446626, 02446634
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2015-07-31
Decision / Authorization Date: 2016-02-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00087
… is used to treat advanced bladder, testicular and ovarian cancers. This safety review was triggered when Health Canada … patients with advanced bladder, testicular and ovarian cancers. Health Canada has therefore asked manufacturers of … with some forms of advanced bladder, testicular and ovarian cancers. Cisplatin has been sold in Canada since 1979. It is …
Issued / Original Publication Date: 2016-02-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00286
Product Type: Drug
Control Number: 181399
DIN(s): 02449498
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-01-26
Updated Date: 2021-11-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00090
… with radioactive iodine refractory differentiated thyroid cancer. Why was the decision issued? In the pivotal Phase … in radioactive iodine-refractory differentiated thyroid cancer patients, Lenvima extended progression-free survival … radioactive iodine-refractory differentiated thyroid cancer. Decision issued Approved; issued Notice of …
Product Type: Drug
Control Number: 180877
DIN(s): 02450291, 02450305, 02450313, 02450321
Manufacturer: Eisai Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-01-08
Decision / Authorization Date: 2015-12-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00339
… of BCL-2 in various hematologic malignancies contributes to cancer cell survival by binding and sequestering high levels … resulting in programmed cell death (apoptosis) of the cancer cells. In non-clinical studies, venetoclax has … resulting in programmed cell death (apoptosis) of the cancer cells. The pharmacokinetics of venetoclax was …
Product Type: Drug
Control Number: 190761
DIN(s): 02458039, 02458047, 02458055, 02458063
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-12-18
Issued / Original Publication Date: 2016-12-22
Decision / Authorization Date: 2016-09-30
Updated Date: 2023-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00004
… used to treat and control benign prostatic hyperplasia (non-cancerous enlargement of the prostate gland). At a lower …
Issued / Original Publication Date: 2015-12-17