Review decisions

Showing 40 results of 332 total
Regulatory Decision Summary for Xcopri
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1693578801415
Product Type: Drug
Control Number: 261689
DIN(s): 02538652, 02538660, 02538725, 02538733, 02538741, 02538814
Manufacturer: Endo Ventures Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-06-09
Decision / Authorization Date: 2023-06-12
Regulatory Decision Summary for Onakta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1688667089344
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
Decision / Authorization Date: 2023-05-12
Regulatory Decision Summary for Ondexxya
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1687460395389
Product Type: Drug
Control Number: 266464
DIN(s): 02538539
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-07-29
Decision / Authorization Date: 2023-06-16
Summary Basis of Decision for Voydeya
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1733496891004
Product Type: Drug
Control Number: 274338
DIN(s): 02550040, 02550059
Manufacturer: Alexion Pharma GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-31
Issued / Original Publication Date: 2024-12-06
Decision / Authorization Date: 2024-07-19
Summary Basis of Decision for Ixchiq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1731445138060
Product Type: Drug
Control Number: 275762
Manufacturer: Valneva Austria GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-29
Issued / Original Publication Date: 2024-11-12
Decision / Authorization Date: 2024-11-12
Regulatory Decision Summary for Quviviq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692293386336
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
Decision / Authorization Date: 2023-04-28
Regulatory Decision Summary for Beyfortus
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1684952482271
Product Type: Drug
Control Number: 269388
DIN(s): 02537206, 02537214
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-11-03
Decision / Authorization Date: 2023-04-19
Regulatory Decision Summary for Verquvo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705595463519
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
Decision / Authorization Date: 2023-04-28
Summary Basis of Decision for Truqap
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1728656969053
Product Type: Drug
Control Number: 274859
DIN(s): 02544733, 02544741
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-28
Issued / Original Publication Date: 2024-10-11
Summary Basis of Decision for Wainua
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1730227073967
Product Type: Drug
Control Number: 274598
DIN(s): 02548909
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-21
Issued / Original Publication Date: 2024-10-29
Decision / Authorization Date: 2024-06-19

Displaying 31 - 40 of 332 | Page 4 of 34
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