Review decisions

Showing 240 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00556
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
Issued / Original Publication Date: 2021-11-10
Decision / Authorization Date: 2021-07-26
Updated Date: 2025-02-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00542
Product Type: Drug
Control Number: 242748
DIN(s): 02512963, 02554267
Manufacturer: Beigene Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-08-12
Issued / Original Publication Date: 2021-07-15
Decision / Authorization Date: 2021-03-01
Updated Date: 2026-02-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00490
Product Type: Drug
Control Number: 229407
DIN(s): 02500337
Manufacturer: Sun Pharma Global FZE
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-08-11
Updated Date: 2022-11-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00554
Product Type: Drug
Control Number: 242300
DIN(s): 02516322
Manufacturer: EMD Serono, A division of EMD Inc. Canada
Submission Type: New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-07-31
Issued / Original Publication Date: 2021-10-21
Decision / Authorization Date: 2021-05-27
Updated Date: 2024-09-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00544
Product Type: Drug
Control Number: 242373
DIN(s): 02514931
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-07-31
Issued / Original Publication Date: 2021-07-27
Decision / Authorization Date: 2021-04-14
Updated Date: 2025-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00527
Product Type: Drug
Control Number: 242196
DIN(s): 02512556
Manufacturer: Ultragenyx Pharmaceutical Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-07-28
Issued / Original Publication Date: 2021-05-03
Decision / Authorization Date: 2021-02-15
Updated Date: 2023-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00539
Product Type: Drug
Control Number: 242104
DIN(s): 02514400
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-07-24
Issued / Original Publication Date: 2021-07-09
Decision / Authorization Date: 2021-04-15
Updated Date: 2025-05-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00491
Product Type: Drug
Control Number: 240551
DIN(s): 02502135, 02502143
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2020-06-19
Issued / Original Publication Date: 2020-08-19
Decision / Authorization Date: 2020-07-27
Updated Date: 2025-05-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1692890357153
Product Type: Drug
Control Number: 240862
DIN(s): 02537044, 02537052, 02537060
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-19
Issued / Original Publication Date: 2023-08-22
Decision / Authorization Date: 2023-04-28
Updated Date: 2025-10-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00587
Product Type: Drug
Control Number: 237499
DIN(s): 02522160, 02522179
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-06-07
Issued / Original Publication Date: 2022-04-21
Decision / Authorization Date: 2021-11-05
Updated Date: 2024-04-02