Review decisions
Showing 250 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00260
… Potential Safety Issues Mycosis fungoides, a type of cancer involving white blood cells, called T lymphocytes, … Goods Administration. Mycosis fungoides is a type of cancer involving white blood cells, called T-lymphocytes, …
Issued / Original Publication Date: 2021-03-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00567
… increased susceptibility to opportunistic infections and cancer. A cumulative total of 84,409 HIV cases have been … with inhibitors of CYP3A4, P-glycoprotein (P-gp), or breast cancer resistance protein (BCRP) may increase temsavir …
Product Type: Drug
Control Number: 250213
DIN(s): 02520869
Manufacturer: ViiV Healthcare ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-03-05
Issued / Original Publication Date: 2022-01-11
Decision / Authorization Date: 2021-10-01
Updated Date: 2025-03-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00829
… to curative therapy) or metastatic non-small cell lung cancer (NSCLC). Why was the decision issued? A … to curative therapy) or metastatic non-small cell lung cancer (NSCLC). Two hundred and seventy five patients were … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. …
Product Type: Drug
Control Number: 237680
DIN(s): 02479206, 02479214, 02479222, 02479230
Manufacturer: Takeda Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-03-27
Decision / Authorization Date: 2021-03-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01016
… (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). After evaluation of the submitted data … of adult patients with metastatic MSI-H or dMMR colorectal cancer (CRC). Why was the decision issued? Authorization …
Product Type: Drug
Control Number: 240864
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-06-19
Decision / Authorization Date: 2021-03-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01016
… le traitement de première ligne des patients atteints d’un cancer colorectal (CRC) présentant une instabilité … comme monothérapie, de patients adultes atteints d’un cancer colorectal (CRC) présentant une IMS-H ou des TsdR. …
Product Type: Drug
Control Number: 240864
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-06-19
Decision / Authorization Date: 2021-03-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00783
… treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have high programmed cell death …
Product Type: Drug
Control Number: 237371
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-03-20
Decision / Authorization Date: 2021-03-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00780
… for the adjuvant treatment of HER2-positive early breast cancer in combination with chemotherapy, and for the treatment of metastatic breast cancer in combination with docetaxel. Why was the decision … study conducted in female patients with HER2+ early breast cancer which demonstrated that exposures to pertuzumab and …
Product Type: Drug
Control Number: 237402
DIN(s): 02512912, 02512920
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-03-20
Decision / Authorization Date: 2021-03-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00782
… for the neoadjuvant treatment of HER2-positive early breast cancer (EBC). After evaluation of the submitted data …
Product Type: Drug
Control Number: 230602
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-08-09
Decision / Authorization Date: 2021-02-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00537
… heart disease, chronic kidney disease, type 2 diabetes, cancer, and pulmonary obstructive disease. In addition, the … based on investigator’s assessment. Examples include: cancer treatment, bone marrow or organ transplantation, …
Product Type: Drug
Control Number: 249830
DIN(s): 02516691, 02516705
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2021-02-24
Issued / Original Publication Date: 2021-07-07
Decision / Authorization Date: 2021-06-09
Updated Date: 2024-09-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00765
… or mismatch repair deficient (dMRR) metastatic colorectal cancer after prior fluoropyrimidine-based therapy in … or mismatch repair deficient (dMMR) metastatic colorectal cancer after prior fluoropyrimidine-based therapy in … or mismatch repair deficient (dMRR) metastatic colorectal cancer (mCRC). In the study, 119 patients were treated with …
Product Type: Drug
Control Number: 239474
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-05-13
Decision / Authorization Date: 2021-02-11