Review decisions
Showing 230 results of 2270 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683132946136
Product Type: Drug
Control Number: 262810
DIN(s): 02468042
Manufacturer: Amicus Therapeutics UK Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-28
Decision / Authorization Date: 2023-03-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1713457878482
Product Type: Drug
Control Number: 273741
DIN(s): 02542641, 02542676, 02542684, 02542692
Manufacturer: Medison Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-03-28
Issued / Original Publication Date: 2024-04-17
Decision / Authorization Date: 2023-10-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1715173505610
Product Type: Drug
Control Number: 273721
DIN(s): 02542560
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-03-27
Issued / Original Publication Date: 2024-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01101
Product Type: Drug
Control Number: 265517
DIN(s): 02536552, 02536560
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-06-23
Decision / Authorization Date: 2023-03-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00630
Product Type: Drug
Control Number: 256568
DIN(s): 02532603
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2023-03-24
Updated Date: 2023-03-24
Summary safety review - Proglycem (diazoxide) - Assessing the Potential Risk of Pericardial Effusion
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00294
Issued / Original Publication Date: 2023-03-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01099
Product Type: Drug
Control Number: 267362
DIN(s): 02536455
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-26
Decision / Authorization Date: 2023-03-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00293
Issued / Original Publication Date: 2023-03-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1722283649339
Product Type: Drug
Control Number: 273519
DIN(s): 02543559, 02543567
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-03-21
Issued / Original Publication Date: 2024-07-29
Decision / Authorization Date: 2023-12-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01098
Product Type: Drug
Control Number: 270857
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission - Confirmatory
Date Filed / Submission Date: 2022-12-20
Decision / Authorization Date: 2023-03-20