Review decisions

Showing 330 results of 2299 total
Regulatory Decision Summary for Polivy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01035
Product Type: Drug
Control Number: 259726
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-17
Decision / Authorization Date: 2022-11-14
Summary Safety Review - Standard Synthetic Mid-urethral Sling - Assessing Long-term Safety and Effectiveness
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00288
Issued / Original Publication Date: 2022-11-14
Regulatory Decision Summary for Ervebo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01027
Product Type: Drug
Control Number: 256568
DIN(s): 02532603
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-09-10
Decision / Authorization Date: 2022-11-09
Regulatory Decision Summary for Radicava
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01059
Product Type: Drug
Control Number: 261904
DIN(s): 02532611
Manufacturer: Mitsubishi Tanabe Pharma Corporation
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-03-02
Decision / Authorization Date: 2022-11-08
Regulatory Decision Summary for Camzyos
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01073
Product Type: Drug
Control Number: 258772
DIN(s): 02532549, 02532557, 02532565, 02532573
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-11-18
Decision / Authorization Date: 2022-11-08
Regulatory Decision Summary for Spikevax Bivalent (Original/Omicron BA.4/5)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01020
Product Type: Drug
Control Number: 267589
DIN(s): 02532352
Manufacturer: ModernaTX, Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-09-12
Decision / Authorization Date: 2022-11-03
Summary Basis of Decision (SBD) for Orgovyx
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1708102173051
Product Type: Drug
Control Number: 269372
DIN(s): 02542137
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-11-03
Issued / Original Publication Date: 2024-02-16
Decision / Authorization Date: 2023-10-10
Regulatory Decision Summary for Kerendia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1695926847771
Product Type: Drug
Control Number: 258231
DIN(s): 02531917, 02531925
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-11-01
Decision / Authorization Date: 2022-10-14
Summary Basis of Decision for Beyfortus
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1686249847840
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
Issued / Original Publication Date: 2023-06-07
Decision / Authorization Date: 2023-04-19
Updated Date: 2024-06-06
Regulatory Decision Summary for Sunlenca
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01044
Product Type: Drug
Control Number: 262999
DIN(s): 02532468, 02532476
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-04-06
Decision / Authorization Date: 2022-11-02

Displaying 321 - 330 of 2299 | Page 33 of 230
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