Review decisions
Showing 340 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00583
… of the PEER registry do not indicate an increased risk of cancer at this time. The overall benefit-risk for Elidel …
Product Type: Drug
Control Number: 220947
Manufacturer: Valeant Canada LP / Valeant Canada S.E.C.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-10-12
Decision / Authorization Date: 2019-09-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00561
… population are those with blood-related disorders or cancer patients requiring platelet transfusion. There is no …
Product Type: Drug
Control Number: 220402
DIN(s): 02492067, 02492075
Manufacturer: Maco Pharma
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-09-21
Decision / Authorization Date: 2019-09-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00636
… for patients with advanced triple-negative breast cancer whose tumours express PD-L1 ≥ 1% and who have not … locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1%, and …
Product Type: Drug
Control Number: 223911
DIN(s): 02492393
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-08-23
Decision / Authorization Date: 2019-09-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00672
… for the treatment of adult patients with germline breast cancer susceptibility gene (BRCA)-mutated human epidermal … 2 (HER2)-negative locally advanced or metastatic breast cancer. Following review, the indication was altered: … with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated human epidermal …
Product Type: Drug
Control Number: 220584
DIN(s): 02492032, 02492040
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-09-28
Decision / Authorization Date: 2019-09-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00549
… held by Herceptin (trastuzumab) in Canada: early breast cancer (EBC); metastatic breast cancer; and metastatic gastric cancer. Why was the decision issued? Herzuma …
Product Type: Drug
Control Number: 210238
DIN(s): 02480794
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-10-24
Decision / Authorization Date: 2019-09-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1685644161223
… for the palliative treatment of advanced epithelial ovarian cancer after at least one line of standard therapy. What did … benefit-harm-uncertainty ratio for the proposed ovarian cancer indication and conditions of use was deemed not … for the proposed indication (i.e., treatment of ovarian cancer), but rather, were for allogenic stem cell …
Product Type: Drug
Control Number: 231223
Manufacturer: Marcan Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-08-30
Decision / Authorization Date: 2021-06-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00550
… locally advanced unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed after …
Product Type: Drug
Control Number: 222188
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Confirmatory
Date Filed / Submission Date: 2018-11-21
Decision / Authorization Date: 2019-08-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00556
… uses currently held by Herceptin in Canada: early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC). Why was the decision issued? Trazimera was …
Product Type: Drug
Control Number: 212140
DIN(s): 02483467, 02483475
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-12-15
Decision / Authorization Date: 2019-08-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00541
… treatment of patients with extensive-stage small cell lung cancer. After evaluation of the submitted data package, … of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Why was the decision issued? The … of adult patients with extensive-stage small cell lung cancer (ES-SCLC) was based on results of a multicentre, …
Product Type: Drug
Control Number: 223753
DIN(s): 02462990
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2019-01-16
Decision / Authorization Date: 2019-08-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00576
… to allow for use in male patients with advanced breast cancer. Data in the submission further supported revisions … the decision issued? Because of the rarity of male breast cancer (BC), randomized clinical studies in this patient …
Product Type: Drug
Control Number: 219500
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-08-24
Decision / Authorization Date: 2019-08-06