Review decisions

Showing 320 results of 2295 total
Summary Basis of Decision for Jamteki
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718291599089
Product Type: Drug
Control Number: 268742
DIN(s): 02543036, 02543044
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-11-24
Issued / Original Publication Date: 2024-06-12
Decision / Authorization Date: 2023-11-09
Summary Basis of Decision for Tezspire
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00613
Product Type: Drug
Control Number: 256188
DIN(s): 02529548, 02529556
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-11-21
Updated Date: 2022-11-21
Regulatory Decision Summary for Slynd
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683208648343
Product Type: Drug
Control Number: 242176
DIN(s): 02522802
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-07-24
Decision / Authorization Date: 2021-11-30
Regulatory Decision Summary for Nuvaxovid
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01024
Product Type: Drug
Control Number: 266285
Manufacturer: Novavax Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-08-05
Decision / Authorization Date: 2022-11-17
Summary Basis of Decision for Wezlana/Wezlana I.V.
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1721675750511
Product Type: Drug
Control Number: 269097
DIN(s): 02544180, 02544199, 02544202, 02544210
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-11-15
Issued / Original Publication Date: 2024-07-22
Decision / Authorization Date: 2023-12-27
Regulatory Decision Summary for Abrilada
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683123488934
Product Type: Drug
Control Number: 259979
DIN(s): 02511045, 02511053, 02511061, 02511088, 02511096
Manufacturer: Pfizer Canada ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-01-17
Decision / Authorization Date: 2022-11-14
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

Displaying 311 - 320 of 2295 | Page 32 of 230
Report a problem or mistake on this page
Please select all that apply:
Date modified: