Review decisions

Showing 70 results of 1324 total
Regulatory Decision Summary for Cysview
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732299832627
Product Type: Drug
Control Number: 273436
DIN(s): 02436639
Manufacturer: Photocure ASA
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-10-05
Decision / Authorization Date: 2023-07-21
Regulatory Decision Summary for Awiqli
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1711383693011
Product Type: Drug
Control Number: 273850
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Decision / Authorization Date: 2024-03-12
Regulatory Decision Summary for Tecentriq / Tecentriq SC
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1711121589642
Product Type: Drug
Control Number: 273807
DIN(s): 02462990, 02492393, 02546310
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-29
Decision / Authorization Date: 2024-03-13
Regulatory Decision Summary for Wyost
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710769045419
Product Type: Drug
Control Number: 267788
DIN(s): 02545764
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Decision / Authorization Date: 2024-03-01
Regulatory Decision Summary for Rexulti
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722024187528
Product Type: Drug
Control Number: 272694
DIN(s): 02461749, 02461757, 02461765, 02461773, 02461781, 02461803
Manufacturer: Otsuka Pharmaceutical Co Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-24
Decision / Authorization Date: 2024-01-23
Regulatory Decision Summary for Jubbonti
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710165579186
Product Type: Drug
Control Number: 271806
DIN(s): 02545411
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Decision / Authorization Date: 2024-02-16
Regulatory Decision Summary for Sandoz Bisoprolol Tablets
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1728415477870
Product Type: Drug
Control Number: 243497
DIN(s): 02494035, 02494043, 02544245, 02544253
Manufacturer: Sandoz Canada Incorporated
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-09-01
Decision / Authorization Date: 2024-01-04
Regulatory Decision Summary for Jardiance
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722022520532
Product Type: Drug
Control Number: 270652
DIN(s): 02443937, 02443945
Manufacturer: Boehringer Ingelheim (Canada) Ltd
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-14
Decision / Authorization Date: 2024-01-18
Regulatory Decision Summary for Tecfidera
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732557043374
Product Type: Drug
Control Number: 259869
DIN(s): 02404508, 02420201
Manufacturer: Biogen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-22
Decision / Authorization Date: 2023-05-18
Regulatory Decision Summary for Rinvoq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1711550170651
Product Type: Drug
Control Number: 257284
DIN(s): 02495155, 02520893, 02539721
Manufacturer: AbbVie corp.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-10-05
Decision / Authorization Date: 2023-07-21

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