Review decisions

Showing 20 results of 56 total
Regulatory Decision Summary for Brukinsa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719947956895
Product Type: Drug
Control Number: 254556
DIN(s): 02512963
Manufacturer: Beigene Switzerland GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-07-09
Decision / Authorization Date: 2022-02-18
Summary Safety Review - Isotretinoin - Assessing the Potential Risk of Sexual Dysfunction, Including Persistent Sexual Dysfunction After Drug Discontinuation
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1717527382406
DIN(s): 00582344, 00582352, 02257955, 02257963, 02309173, 02396971, 02396998, 02397005, 02397013, 02539047, 02539055, 02539063, 02539071
Issued / Original Publication Date: 2024-06-07
Updated Date: 2024-06-07
Regulatory Decision Summary for Talvey
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1717432595126
Product Type: Drug
Control Number: 278277
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-08-15
Decision / Authorization Date: 2024-04-30
Summary Basis of Decision for Prehevbrio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1688740135719
Product Type: Drug
Control Number: 259302
DIN(s): 02533286
Manufacturer: VBI Vaccines Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-07-08
Issued / Original Publication Date: 2023-07-06
Decision / Authorization Date: 2022-12-06
Updated Date: 2024-06-17
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 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
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
Summary Basis of Decision (SBD) for Arexvy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1701180125532
Product Type: Drug
Control Number: 269021
DIN(s): 02540207
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-25
Issued / Original Publication Date: 2023-11-18
Decision / Authorization Date: 2023-08-04
Updated Date: 2024-06-28
Summary Basis of Decision for Litfulo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1721405092068
Product Type: Drug
Control Number: 268723
DIN(s): 02543532
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-14
Issued / Original Publication Date: 2024-07-18
Summary Basis of Decision for Ranopto
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1717516069966
Product Type: Drug
Control Number: 268288
DIN(s): 02542250
Manufacturer: Teva Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-10-04
Issued / Original Publication Date: 2024-06-04

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