Review decisions
Showing 420 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00445
… of Verzenio as maintenance therapy in Early Breast Cancer (EBC) with the removal of the Ki-67 score as a … receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on … receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on …
Product Type: Drug
Control Number: 215268
DIN(s): 02487098, 02487101, 02487128, 02487136
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-04-16
Issued / Original Publication Date: 2019-09-26
Decision / Authorization Date: 2019-04-05
Updated Date: 2024-11-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00354
… with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based … in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who had experienced disease progression … with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based …
Product Type: Drug
Control Number: 205038
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-04-26
Decision / Authorization Date: 2018-04-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00357
… active controlled study in patients with early breast cancer receiving TAC (docetaxel, doxorubicin, cyclophosphamide) anticancer chemotherapy in the adjuvant setting. No clinically …
Product Type: Drug
Control Number: 204841
DIN(s): 02474565
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-21
Decision / Authorization Date: 2018-04-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00367
… is consistent with that reported in previous studies with cancer populations. Xgeva is associated with increased risks …
Product Type: Drug
Control Number: 205235
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-02
Decision / Authorization Date: 2018-04-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00447
… locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor … locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor … locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor …
Product Type: Drug
Control Number: 214572
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-03-16
Issued / Original Publication Date: 2019-10-22
Decision / Authorization Date: 2019-02-26
Updated Date: 2025-02-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00457
… by a qualified physician experienced in the use of anticancer therapies. Furthermore, it specifies that concomitant … by a qualified physician experienced in the use of anticancer therapies. Furthermore, it specifies that concomitant … Acalabrutinib was a substrate for P-glycoprotein and breast cancer resistance protein in vitro. Safety pharmacology …
Product Type: Drug
Control Number: 214504
DIN(s): 02491788, 02535696
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2018-03-15
Issued / Original Publication Date: 2020-01-13
Decision / Authorization Date: 2019-08-23
Updated Date: 2025-05-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00194
… authorized for sale in Canada to treat some types of breast cancers and soft-tissue cancers (liposarcomas). Health Canada reviewed the risk of … certain types of breast and soft-tissue (liposarcomas) cancers. Halaven has been marketed in Canada since 2012. …
Issued / Original Publication Date: 2018-03-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00193
… in the body) that may mimic the local re-appearance of cancer Key Messages SurgiWrap is a medical device authorized … could produce a mass that mimics a local re-appearance of cancer. This safety review was triggered after Health Canada … to the development of FBRs mimicking the re-appearance of cancer. Since the Instruction for Use manual for SurgiWrap …
Issued / Original Publication Date: 2018-03-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00352
… receptor 2 (HER2)-negative advanced or metastatic breast cancer as initial endocrine-based therapy. Why was the … receptor 2 (HER2)-negative advanced or metastatic breast cancer as an initial endocrine-based therapy. The efficacy …
Product Type: Drug
Control Number: 203884
DIN(s): 02473569
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-03-17
Decision / Authorization Date: 2018-03-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00486
… use in the treatment of the following patient populations: Cancer patients receiving myelosuppressive chemotherapy … Nivestym is indicated in adult and pediatric patients with cancer receiving myelosuppressive chemotherapy. A complete … and consolidation treatment for acute myeloid leukemia. Cancer patients receiving myeloablative chemotherapy …
Product Type: Drug
Control Number: 214080
DIN(s): 02485575, 02485583, 02485591, 02485656
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-02-28
Issued / Original Publication Date: 2020-07-30
Decision / Authorization Date: 2020-04-16
Updated Date: 2024-08-06