Review decisions

Showing 160 results of 2295 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698761313167
Product Type: Drug
Control Number: 246125
DIN(s): 02536145
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-12-04
Decision / Authorization Date: 2023-05-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698780442306
Product Type: Drug
Control Number: 264296
DIN(s): 02537532
Manufacturer: Acutis Biotherapeutics, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-05-13
Decision / Authorization Date: 2023-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1701375559096
Product Type: Drug
Control Number: 265619
DIN(s): 02538881
Manufacturer: Sun Pharmaceutical Industries Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-06-29
Decision / Authorization Date: 2023-06-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1709650631485
Product Type: Drug
Control Number: 253186
DIN(s): 02533979, 02533987, 02533995
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-05-28
Decision / Authorization Date: 2022-12-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698758419366
Product Type: Drug
Control Number: 259397
DIN(s): 02533030
Manufacturer: Bristol-Myers Squibb
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-12-08
Decision / Authorization Date: 2023-11-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1701377700366
Product Type: Drug
Control Number: 258574
DIN(s): 02497220, 02497247
Manufacturer: ViiV Healthcare ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-11-12
Decision / Authorization Date: 2022-12-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1696010036746
Product Type: Drug
Control Number: 272688
DIN(s): 02541769
Manufacturer: Ultragenyx Pharmaceutical Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-02-24
Decision / Authorization Date: 2023-09-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1695648310158
Product Type: Drug
Control Number: 256629
DIN(s): 02541416
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-06-01
Decision / Authorization Date: 2023-09-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1695999988500
Product Type: Drug
Control Number: 267438
Manufacturer: Argenx BV
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-19
Decision / Authorization Date: 2023-09-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697216175270
Product Type: Drug
Control Number: 243224
DIN(s): 02541602, 02541610, 02541629, 02541637
Manufacturer: KYE Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-20
Decision / Authorization Date: 2023-09-21