Review decisions

Showing 110 results of 2295 total
Regulatory Decision Summary for Olumiant
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710876504060
Product Type: Drug
Control Number: 270684
DIN(s): 02480018, 02544768
Manufacturer: Eli Lily Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-15
Decision / Authorization Date: 2024-01-26
Regulatory Decision Summary for Epidiolex
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714138409580
Product Type: Drug
Control Number: 268559
DIN(s): 02543079
Manufacturer: GW Research Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-10-07
Decision / Authorization Date: 2023-11-15
Summary Safety Review - Amiodarone - Assessing the Potential Risk of Primary Graft Dysfunction Following Heart Transplantation
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1706035839788
DIN(s): 02239835, 02242325, 02242472, 02243836, 02245248, 02246194, 02246331, 02247217, 02249502, 02292173, 02294508, 02309661, 02364336, 02385465, 02423227, 02427346, 02531844
Issued / Original Publication Date: 2024-02-01
Updated Date: 2024-02-01
Regulatory Decision Summary for Ozempic
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706278116175
Product Type: Drug
Control Number: 271108
DIN(s): 02471469, 02471477, 02523930, 02540258
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-01-04
Decision / Authorization Date: 2023-08-04
Regulatory Decision Summary for Sibboran
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708015333213
Product Type: Drug
Control Number: 259953
DIN(s): 02543338
Manufacturer: Trimedic Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-30
Decision / Authorization Date: 2023-11-20
Regulatory Decision Summary for Eligard
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708632207803
Product Type: Drug
Control Number: 269016
DIN(s): 02248239, 02248240, 02248999, 02268892
Manufacturer: Tolmar International Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-10-25
Decision / Authorization Date: 2023-09-21
Regulatory Decision Summary for Myfembree
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710259036712
Product Type: Drug
Control Number: 267148
DIN(s): 02541742
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-18
Decision / Authorization Date: 2023-09-22
Regulatory Decision Summary for Imbruvica
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706712320386
Product Type: Drug
Control Number: 266710
DIN(s): 02434407, 02486733, 02486741, 02486768, 02486776, 02540215
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-08-04
Decision / Authorization Date: 2023-08-04
Regulatory Decision Summary for Myalepta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706026709659
Product Type: Drug
Control Number: 273908
DIN(s): 02544555, 02544563, 02544571
Manufacturer: Amryt Pharmaceuticals DAC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Decision / Authorization Date: 2024-01-17
Summary Safety Review - Colistin (colistimethate sodium) - Assessing the Potential Risk of Pseudo-Bartter Syndrome
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1705515920269
DIN(s): 00476420, 02244849, 02403544
Issued / Original Publication Date: 2024-01-18
Updated Date: 2024-01-18

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