Review decisions
Showing 40 results of 56 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00586
Product Type: Drug
Control Number: 245877
DIN(s): 02521288, 02540193
Manufacturer: Leo Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-10-30
Issued / Original Publication Date: 2022-04-19
Decision / Authorization Date: 2021-10-13
Updated Date: 2024-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00542
Product Type: Drug
Control Number: 242748
DIN(s): 02512963
Manufacturer: Beigene Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-08-12
Issued / Original Publication Date: 2021-07-15
Decision / Authorization Date: 2021-03-01
Updated Date: 2024-06-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00532
Product Type: Drug
Control Number: 232449
DIN(s): 02510995
Manufacturer: Dutch Ophthalmic Research Center International BV
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-11-07
Issued / Original Publication Date: 2021-06-02
Decision / Authorization Date: 2021-01-15
Updated Date: 2024-06-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00516
Product Type: Drug
Control Number: 230825
DIN(s): 02502895
Manufacturer: Elusys Therapeutics, Inc.
Submission Type: Extraordinary Use New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-08-16
Issued / Original Publication Date: 2021-01-28
Decision / Authorization Date: 2020-07-30
Updated Date: 2024-06-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00502
Product Type: Drug
Control Number: 229866
DIN(s): 02502445
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-07-19
Issued / Original Publication Date: 2020-10-22
Decision / Authorization Date: 2020-07-27
Updated Date: 2024-07-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00569
Product Type: Drug
Control Number: 220512
DIN(s): 02520990, 02521008
Manufacturer: Tanvex BioPharma USA, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-01-17
Issued / Original Publication Date: 2022-01-18
Decision / Authorization Date: 2021-10-08
Updated Date: 2024-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00460
Product Type: Drug
Control Number: 215288
DIN(s): 02493012
Manufacturer: Cipher Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-09-20
Issued / Original Publication Date: 2020-01-27
Decision / Authorization Date: 2019-10-10
Updated Date: 2024-06-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00441
Product Type: Drug
Control Number: 217033
DIN(s): 02485427, 02485435
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-06-15
Issued / Original Publication Date: 2019-08-19
Decision / Authorization Date: 2019-02-06
Updated Date: 2024-06-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00415
Product Type: Drug
Control Number: 210369
DIN(s): 02479206, 02479214, 02479222, 02479230
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-10-17
Issued / Original Publication Date: 2019-01-28
Decision / Authorization Date: 2018-07-26
Updated Date: 2024-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00409
Product Type: Drug
Control Number: 205392
DIN(s): 02478498
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-05-09
Issued / Original Publication Date: 2018-11-27
Decision / Authorization Date: 2018-07-10
Updated Date: 2024-06-14