Review decisions
Showing 139 results of 139 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1693591697586
Product Type: Drug
Control Number: 261689
DIN(s): 02538652, 02538660, 02538725, 02538733, 02538741, 02538768, 02538776, 02538784, 02538792, 02538806, 02538814
Manufacturer: Endo Ventures Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-06-09
Issued / Original Publication Date: 2023-08-31
Decision / Authorization Date: 2023-06-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1687370834165
Product Type: Drug
Control Number: 263638
DIN(s): 02537117
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-04-22
Issued / Original Publication Date: 2023-06-21
Decision / Authorization Date: 2023-04-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1689944674439
Product Type: Drug
Control Number: 262080
DIN(s): 02537818
Manufacturer: Avir Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-04-08
Issued / Original Publication Date: 2023-07-20
Decision / Authorization Date: 2023-05-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1687791867767
Product Type: Drug
Control Number: 262815
Manufacturer: Red Leaf Medical Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-03-25
Decision / Authorization Date: 2023-05-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1691500592141
Product Type: Drug
Control Number: 255507
DIN(s): 02537435, 02537443
Manufacturer: Idorsia Pharmaceuticals Ltd
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-25
Issued / Original Publication Date: 2023-08-04
Decision / Authorization Date: 2023-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692287802053
Product Type: Drug
Control Number: 255132
Manufacturer: Porton Biopharma Ltd.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2021-07-27
Decision / Authorization Date: 2023-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1691759711587
Product Type: Drug
Control Number: 253850
Manufacturer: Prestige Biopharma Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-05
Decision / Authorization Date: 2023-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692978760470
Product Type: Drug
Control Number: 240372
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-13
Decision / Authorization Date: 2023-05-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1692890357153
Product Type: Drug
Control Number: 240862
DIN(s): 02537044, 02537052, 02537060
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-19
Issued / Original Publication Date: 2023-08-22
Decision / Authorization Date: 2023-04-28