Review decisions
Showing 470 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00157
… antivirals (DAAs) Potential Safety Issue Liver cancer recurrence Key Messages Direct-acting antivirals … serious scarring of the liver (cirrhosis) or liver cancer. Health Canada reviewed the potential risk of liver cancer coming back (recurrence) with the use of DAAs, …
Issued / Original Publication Date: 2017-04-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00396
… favourable benefit-risk profile for the treatment of cancer patients with non-myeloid malignancies undergoing … active-controlled study in patients with early breast cancer receiving docetaxel, doxorubicin, and cyclophosphamide (the TAC regimen) anticancer chemotherapy in the adjuvant setting. No clinically …
Product Type: Drug
Control Number: 204841
DIN(s): 02474565, 02529343
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-21
Issued / Original Publication Date: 2018-07-06
Decision / Authorization Date: 2018-04-05
Updated Date: 2025-02-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00448
… treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or … growth factor receptor 2 (HER2)-positive metastatic breast cancer. The market authorization was based on the quality … relating to the following conditions: Early breast cancer Ogivri (trastuzumab) is indicated for the treatment …
Product Type: Drug
Control Number: 204579
DIN(s): 02474425, 02474433
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-18
Issued / Original Publication Date: 2019-10-23
Decision / Authorization Date: 2019-05-03
Updated Date: 2024-02-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00373
… efflux transporters P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP), hepatic uptake …
Product Type: Drug
Control Number: 204165
DIN(s): 02469367, 02469375, 02469383, 02469405
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-04-10
Issued / Original Publication Date: 2018-06-04
Decision / Authorization Date: 2017-11-01
Updated Date: 2025-07-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00246
… indication for chemorefractory metastatic colorectal cancer from the wild-type KRAS tumours to the wild-type RAS …
Product Type: Drug
Control Number: 193962
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-03-31
Decision / Authorization Date: 2017-04-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00154
… than the jawbone (non-mandibular osteonecrosis) in adult cancer patients Key Messages Avastin (bevacizumab) is a … used alone or with chemotherapy to treat certain types of cancer. Health Canada reviewed the risk of damage in bones … than the jawbone (non-mandibular osteonecrosis) in adult cancer patients treated with Avastin (bevacizumab) following …
Issued / Original Publication Date: 2017-04-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00430
… lesions in patients with known or suspected breast cancer on the basis of previous mammography or ultrasound … the detection of malignant lesions in patients where breast cancer is known or suspected on the basis of previous … MRI than with Magnevist-enhanced MRI for each type of cancer, i.e., invasive ductal carcinoma, invasive lobular …
Product Type: Drug
Control Number: 188279
Manufacturer: Bracco Imaging Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-10-06
Decision / Authorization Date: 2017-04-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00240
… for locally advanced or metastatic non-small cell lung cancer (NSCLC), based on the results of IUNO and SATURN … with locally advanced or metastatic non-small cell lung cancer whose tumors have activating mutations in the …
Product Type: Drug
Control Number: 194018
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-04-06
Decision / Authorization Date: 2017-03-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00153
… the esophagus to widen areas that have become narrow due to cancer or scarring, or to seal off leaks in the esophagus. … esophagus to widen areas that have become narrow because of cancer or scarring, or to seal off leaks in the esophagus. …
Issued / Original Publication Date: 2017-03-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00385
… has been demonstrated in a syngeneic mouse model of colon cancer. The toxicity of avelumab was evaluated in cynomolgus …
Product Type: Drug
Control Number: 204052
DIN(s): 02469723
Manufacturer: EMD Serono, A division of EMD Inc. Canada
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2017-03-23
Issued / Original Publication Date: 2018-03-09
Decision / Authorization Date: 2017-12-08
Updated Date: 2025-06-04