Review decisions
Showing 100 results of 332 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01004
Product Type: Drug
Control Number: 236566
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-02-26
Decision / Authorization Date: 2021-10-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00919
Product Type: Drug
Control Number: 249486
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-02-12
Decision / Authorization Date: 2021-10-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00880
Product Type: Drug
Control Number: 242569
DIN(s): 02519933, 02519941, 02519968
Manufacturer: Incyte Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-09-10
Decision / Authorization Date: 2021-09-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00615
Product Type: Drug
Control Number: 254548
DIN(s): 02529688
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-09-10
Issued / Original Publication Date: 2022-12-16
Decision / Authorization Date: 2022-08-16
Updated Date: 2023-08-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1691500592141
Product Type: Drug
Control Number: 255507
DIN(s): 02537435, 02537443
Manufacturer: Idorsia Pharmaceuticals Ltd
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-25
Issued / Original Publication Date: 2023-08-04
Decision / Authorization Date: 2023-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1723561016707
Product Type: Drug
Control Number: 255697
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-12
Decision / Authorization Date: 2024-06-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00982
Product Type: Drug
Control Number: 243470
DIN(s): 02518376
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-08-31
Decision / Authorization Date: 2021-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684935203980
Product Type: Drug
Control Number: 255032
DIN(s): 02534622
Manufacturer: Chiesi Farmaceutici S.p.a.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-07-22
Issued / Original Publication Date: 2023-05-23
Decision / Authorization Date: 2023-01-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00604
Product Type: Drug
Control Number: 253904
DIN(s): 02527618
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-06-18
Issued / Original Publication Date: 2022-08-31
Decision / Authorization Date: 2022-05-27
Updated Date: 2024-08-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00619
Product Type: Drug
Control Number: 253502
DIN(s): 02527707
Manufacturer: Amylyx Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-06-07
Issued / Original Publication Date: 2022-12-23
Decision / Authorization Date: 2022-06-10
Updated Date: 2024-11-18