Review decisions
Showing 580 results of 2627 total
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/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
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
Updated Date: 2025-05-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683129818889
Product Type: Drug
Control Number: 254426
DIN(s): 02534681, 02534703
Manufacturer: Apotex Inc
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2021-07-28
Decision / Authorization Date: 2023-02-06
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683135458461
Product Type: Drug
Control Number: 259246
DIN(s): 02491788, 02535696
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-01-25
Decision / Authorization Date: 2023-03-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683205896033
Product Type: Drug
Control Number: 254316
DIN(s): 02414295
Manufacturer: Celgene Inc.
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-06-30
Decision / Authorization Date: 2023-03-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01090
Product Type: Drug
Control Number: 262141
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-08
Decision / Authorization Date: 2023-03-07