Review decisions

Showing 80 results of 1257 total
Regulatory Decision Summary for Hyrimoz
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698157968254
Product Type: Drug
Control Number: 272451
DIN(s): 02542315, 02542323, 02542331, 02542358, 02542366
Manufacturer: Sandoz Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-27
Decision / Authorization Date: 2023-10-13
Regulatory Decision Summary for Rinvoq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698845236805
Product Type: Drug
Control Number: 267554
DIN(s): 02495155, 02520893, 02539721
Manufacturer: AbbVie corp.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-11-16
Decision / Authorization Date: 2023-10-12
Regulatory Decision Summary for Prevymis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698782364007
Product Type: Drug
Control Number: 272553
DIN(s): 02469367, 02469375, 02469383, 02469405
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-20
Decision / Authorization Date: 2023-09-21
Regulatory Decision Summary for Delstrigo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698843751956
Product Type: Drug
Control Number: 266249
DIN(s): 02482592
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-07-20
Decision / Authorization Date: 2023-07-06
Regulatory Decision Summary for Zimed PF
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698760127896
Product Type: Drug
Control Number: 259843
DIN(s): 02533464
Manufacturer: Aequus Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-12-20
Decision / Authorization Date: 2022-12-14
Regulatory Decision Summary for Zoryve
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
Regulatory Decision Summary for Micro+ TE Pediatric
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
Regulatory Decision Summary for Winlevi
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
Regulatory Decision Summary for Qulipta
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
Regulatory Decision Summary for Sotyktu
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

Displaying 71 - 80 of 1257 | Page 8 of 126
Report a problem or mistake on this page
Please select all that apply:
Date modified: