Review decisions

Showing 40 results of 2299 total
Summary Safety Review - Breast Implants - Assessing the Potential Risk of Breast Implant Illness Representative Symptoms and Diseases
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1722261038121
Issued / Original Publication Date: 2024-08-09
Updated Date: 2024-08-09
Regulatory Decision Summary for Steqeyma/Steqeyma IV
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722628438095
Product Type: Drug
Control Number: 274939
DIN(s): 02550245, 02550253, 02550261
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-30
Decision / Authorization Date: 2024-07-30
Regulatory Decision Summary for Argatroban
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1729525313633
Product Type: Drug
Control Number: 282415
DIN(s): 02243835, 02548968
Manufacturer: Sandoz Canada Incorporated
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-12-22
Decision / Authorization Date: 2024-06-28
Regulatory Decision Summary for Tecentriq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1721931544640
Product Type: Drug
Control Number: 254159
DIN(s): 02462990, 02492393
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-25
Decision / Authorization Date: 2022-03-29
Regulatory Decision Summary for Vabysmo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722952436074
Product Type: Drug
Control Number: 278042
DIN(s): 02527618
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-08-08
Decision / Authorization Date: 2024-07-24
Regulatory Decision Summary for Xenpozyme
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1723644947965
Product Type: Drug
Control Number: 275236
DIN(s): 02545713, 02545721
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-12
Decision / Authorization Date: 2024-02-28
Regulatory Decision Summary for Keytruda (pembrolizumab)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722962428155
Product Type: Drug
Control Number: 273487
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-20
Decision / Authorization Date: 2024-03-21
Regulatory Decision Summary for Carvykti
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722614231303
Product Type: Drug
Control Number: 277017
DIN(s): 02535270
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-07-07
Decision / Authorization Date: 2024-07-19
Regulatory Decision Summary for Praluent
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1721416399864
Product Type: Drug
Control Number: 263226
DIN(s): 02547732
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-04-08
Decision / Authorization Date: 2024-05-15
Regulatory Decision Summary for Trikafta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1725974335075
Product Type: Drug
Control Number: 282009
DIN(s): 02517140, 02526670, 02542277, 02542285
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-12-13
Decision / Authorization Date: 2024-07-12

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