Review decisions
Showing 350 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00502
… of serious heart-related problems, fatal blood clots and cancer ), containing important information about labelling … to the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) also …
Product Type: Drug
Control Number: 229866
DIN(s): 02502445
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-07-19
Issued / Original Publication Date: 2020-10-22
Decision / Authorization Date: 2020-07-27
Updated Date: 2024-07-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00658
… with early-stage HER2-overexpressed/ amplified breast cancer, to follow adjuvant trastuzumab based therapy. … receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based … with early-stage HER2-overexpressed/amplified breast cancer following trastuzumab-based adjuvant therapy. The …
Product Type: Drug
Control Number: 218224
DIN(s): 02490536
Manufacturer: Puma Biotechnology Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-07-19
Decision / Authorization Date: 2019-07-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00673
… decision issued? Tropomyosin receptor kinase (TRK) fusion cancer is a genetically defined cancer occurring in a histologically diverse group of … types, with low frequency expression in some common adult cancers and either common or up to 100% expression in some …
Product Type: Drug
Control Number: 219998
DIN(s): 02490315, 02490323, 02490331
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-09-18
Decision / Authorization Date: 2019-07-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00509
… and second primary malignancies (mainly non-melanoma skin cancers) occurred more commonly in the Isa-Pd group and a … S6(R1) and S9 guidelines for non-clinical evaluation of anticancer pharmaceuticals and biotechnology-derived …
Product Type: Drug
Control Number: 229245
DIN(s): 02498235, 02498243
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-06-28
Issued / Original Publication Date: 2020-12-08
Decision / Authorization Date: 2020-04-29
Updated Date: 2024-09-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00657
… epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to … female patients with platinum-sensitive, recurrent ovarian cancer and who demonstrated response to platinum-based … divided into two main cohorts: those with germline breast cancer susceptibility gene (BRCA) mutation tumours …
Product Type: Drug
Control Number: 216792
DIN(s): 02489783
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-06-04
Decision / Authorization Date: 2019-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00225
… used alone, or in combination, to treat different types of cancers, including cancers of the skin, kidney, lung, and liver. Health Canada … authorized for sale in Canada to treat different types of cancers. Used either alone, or in combination, they help …
Issued / Original Publication Date: 2019-06-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00524
… for the following indications: metastatic colorectal cancer locally advanced, recurrent non-small cell lung cancer (NSCLC) platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer, and malignant glioma. Why was the decision issued? …
Product Type: Drug
Control Number: 218183
DIN(s): 02489430, 02489449
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-07-13
Decision / Authorization Date: 2019-06-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00224
… Antibacterial Foam Dressings Potential Safety Issue Cancer Key Messages Gentiane Violet Liquid Topical (gentian … to gentian violet in food because of its potential to cause cancer. 1 Health Canada's risk assessment of medical devices … limited exposure to gentian violet, did not find a risk of cancer. However, no evidence to support the safety of the …
Issued / Original Publication Date: 2019-06-12
Updated Date: 2019-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00476
… Based on in vitro studies, tafamidis inhibits breast cancer resistant protein (BCRP), both systemically and in …
Product Type: Drug
Control Number: 228368
DIN(s): 02495732
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-06-03
Issued / Original Publication Date: 2020-05-21
Decision / Authorization Date: 2020-01-20
Updated Date: 2025-03-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00223
… is a serious but rare type of non-Hodgkin lymphoma (a cancer that affects the immune system) that may develop many … The first case was described in 1997 1 . It is not a cancer of the breast tissue. BIA-ALCL usually presents as an … cases to 26. One case involved metastatic disease, where cancer spread to other parts of the body. The implant …
Issued / Original Publication Date: 2019-05-28
Updated Date: 2019-05-30