Review decisions

Showing 10 results of 1220 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708630999500
Product Type: Drug
Control Number: 272981
DIN(s): 02511576, 02511584
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-02
Decision / Authorization Date: 2024-02-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708454547343
Product Type: Drug
Control Number: 275152
DIN(s): 02459787, 02459795, 02545136, 02545144, 02545152, 02545160
Manufacturer: Novartis Pharmaceuticals Canada Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-10
Decision / Authorization Date: 2024-02-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708464933703
Product Type: Drug
Control Number: 273166
DIN(s): 01981501, 02531577, 02531585
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-10
Decision / Authorization Date: 2024-02-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708462789662
Product Type: Drug
Control Number: 266553
DIN(s): 02544334, 02544342
Manufacturer: B. Braun Medical Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-08-22
Decision / Authorization Date: 2024-01-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708351809911
Product Type: Drug
Control Number: 258157
DIN(s): 02543745
Manufacturer: Xediton Pharmaceuticals
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-10-29
Decision / Authorization Date: 2023-12-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1707836185816
Product Type: Drug
Control Number: 275853
DIN(s): 02544156
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-06-01
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1707495404187
Product Type: Drug
Control Number: 272409
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-14
Decision / Authorization Date: 2024-02-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706278116175
Product Type: Drug
Control Number: 271108
DIN(s): 02471469, 02471477, 02523930, 02540258
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-01-04
Decision / Authorization Date: 2023-08-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706712320386
Product Type: Drug
Control Number: 266710
DIN(s): 02434407, 02486733, 02486741, 02486768, 02486776, 02540215
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-08-04
Decision / Authorization Date: 2023-08-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708632207803
Product Type: Drug
Control Number: 269016
DIN(s): 02248239, 02248240, 02248999, 02268892
Manufacturer: Tolmar International Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-10-25
Decision / Authorization Date: 2023-09-21