Review decisions
Showing 860 results of 2304 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00683
Product Type: Drug
Control Number: 235450
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-01-24
Decision / Authorization Date: 2020-08-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00679
Product Type: Drug
Control Number: 236255
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-02-19
Decision / Authorization Date: 2020-08-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00674
Product Type: Drug
Control Number: 231580
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-09-13
Decision / Authorization Date: 2020-07-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00692
Product Type: Drug
Control Number: 232685
DIN(s): 02502984
Manufacturer: Catalyst Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-11-06
Decision / Authorization Date: 2020-07-31
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/RDS00686
Product Type: Drug
Control Number: 212427
DIN(s): 02502917
Manufacturer: Pharmascience Inc.
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2017-12-27
Decision / Authorization Date: 2020-07-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00680
Product Type: Drug
Control Number: 230825
DIN(s): 02502895
Manufacturer: Elusys Therapeutics Inc.
Submission Type: Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2019-08-16
Decision / Authorization Date: 2020-07-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00690
Product Type: Drug
Control Number: 231031
DIN(s): 02502712
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-08-22
Decision / Authorization Date: 2020-07-29
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/RDS00669
Product Type: Drug
Control Number: 240551
DIN(s): 02502135, 02502143
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-19
Decision / Authorization Date: 2020-07-27