Review decisions
Showing 280 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00503
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
Issued / Original Publication Date: 2020-10-30
Decision / Authorization Date: 2020-07-31
Updated Date: 2023-02-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00513
Product Type: Drug
Control Number: 233058
DIN(s): 02506440, 02506459, 02506467, 02506475, 02506483, 02506491, 02506505, 02506513
Manufacturer: Juno Pharmaceuticals Corp.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-10-31
Issued / Original Publication Date: 2020-01-07
Decision / Authorization Date: 2020-10-14
Updated Date: 2024-08-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00530
Product Type: Drug
Control Number: 233097
DIN(s): 02505851
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-10-31
Issued / Original Publication Date: 2021-05-17
Decision / Authorization Date: 2020-10-13
Updated Date: 2023-10-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00515
Product Type: Drug
Control Number: 226573
DIN(s): 02506564, 02506572, 02529254
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-10-30
Issued / Original Publication Date: 2021-01-27
Decision / Authorization Date: 2020-10-15
Updated Date: 2023-08-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00508
Product Type: Drug
Control Number: 232761
DIN(s): 02505991, 02506009
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-10-25
Issued / Original Publication Date: 2020-12-02
Decision / Authorization Date: 2020-10-02
Updated Date: 2025-06-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00499
Product Type: Drug
Control Number: 232303
DIN(s): 02499614, 02515431
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2019-10-07
Issued / Original Publication Date: 2020-10-08
Decision / Authorization Date: 2020-07-09
Updated Date: 2025-09-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00526
Product Type: Drug
Control Number: 232078
DIN(s): 02508052, 02508060
Manufacturer: Rigel Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-09-30
Issued / Original Publication Date: 2021-03-31
Decision / Authorization Date: 2020-11-19
Updated Date: 2023-07-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00540
Product Type: Drug
Control Number: 231767
DIN(s): 02509075, 02509083, 02509091, 02509105, 02509113, 02509121, 02509148, 02509156
Manufacturer: Shenzhen Techdow Pharmaceutical Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-09-20
Issued / Original Publication Date: 2021-07-12
Decision / Authorization Date: 2020-12-07
Updated Date: 2024-05-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00529
Product Type: Drug
Control Number: 231286
DIN(s): 02507366, 02507374
Manufacturer: Eisai Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-09-03
Issued / Original Publication Date: 2021-05-13
Decision / Authorization Date: 2020-11-04
Updated Date: 2025-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00518
Product Type: Drug
Control Number: 230637
DIN(s): 02502666, 02502674, 02502682
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-08-19
Issued / Original Publication Date: 2021-02-08
Decision / Authorization Date: 2020-10-30
Updated Date: 2024-02-12