Review decisions

Showing 410 results of 2299 total
Summary Basis of Decision (SBD) for Ondexxya
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1700081467048
Product Type: Drug
Control Number: 266464
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-07-29
Issued / Original Publication Date: 2023-11-09
Regulatory Decision Summary for Tezspire
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00977
Product Type: Drug
Control Number: 256188
DIN(s): 02529548, 02529556
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-08-28
Decision / Authorization Date: 2022-07-28
Summary Basis of Decision for Tavneos
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00597
Product Type: Drug
Control Number: 248255
DIN(s): 02526662
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-07-28
Regulatory Decision Summary for Lynparza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00989
Product Type: Drug
Control Number: 259417
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-12-09
Decision / Authorization Date: 2022-07-27
Summary Basis of Decision for Omvoh
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1695821197450
Product Type: Drug
Control Number: 266471
DIN(s): 02539845, 02539853, 02539861
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-07-27
Issued / Original Publication Date: 2023-09-25
Decision / Authorization Date: 2023-07-20
Updated Date: 2024-06-06
Regulatory Decision Summary for Opdivo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01077
Product Type: Drug
Control Number: 257103
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-09-29
Decision / Authorization Date: 2022-07-25
Summary Basis of Decision for Comirnaty Original/Omicron BA.1
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1715956069651
Product Type: Drug
Control Number: 266189
DIN(s): 02532018
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-07-25
Issued / Original Publication Date: 2022-12-19
Decision / Authorization Date: 2022-10-21
Updated Date: 2024-05-17
Regulatory Decision Summary for Orencia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00976
Product Type: Drug
Control Number: 255926
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-08-20
Decision / Authorization Date: 2022-07-21
Regulatory Decision Summary for Trurapi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00979
Product Type: Drug
Control Number: 254352
DIN(s): 02529254
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-07-02
Decision / Authorization Date: 2022-07-20
Summary Safety Review - Cholinesterase Inhibitors (donepezil-, rivastigmine- and galantamine-containing products) - Assessing the Potential Risk of QT Interval Prolongation and Torsade de Pointes
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00285
Issued / Original Publication Date: 2022-07-19

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