Review decisions

Showing 130 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1719417006477
Product Type: Drug
Control Number: 268384
DIN(s): 02543605
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-03
Issued / Original Publication Date: 2024-06-26
Decision / Authorization Date: 2023-12-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718207489396
Product Type: Drug
Control Number: 268282
DIN(s): 02542943
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-09-29
Issued / Original Publication Date: 2024-06-11
Decision / Authorization Date: 2023-11-08
Updated Date: 2025-04-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00617
Product Type: Drug
Control Number: 267589
DIN(s): 02532352
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-09-12
Issued / Original Publication Date: 2023-01-05
Decision / Authorization Date: 2022-11-03
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00612
Product Type: Drug
Control Number: 267502
DIN(s): 02531461, 02533197, 02541025
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-09-02
Issued / Original Publication Date: 2022-12-05
Decision / Authorization Date: 2022-10-07
Updated Date: 2024-09-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1709043672605
Product Type: Drug
Control Number: 267438
DIN(s): 02541599
Manufacturer: Argenx BV
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-29
Issued / Original Publication Date: 2024-02-24
Decision / Authorization Date: 2023-09-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1700071951489
Product Type: Drug
Control Number: 267443
DIN(s): 02539934, 02539942, 02539950
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-29
Issued / Original Publication Date: 2023-11-15
Decision / Authorization Date: 2023-07-26
Updated Date: 2025-01-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1687438952638
Product Type: Drug
Control Number: 267362
DIN(s): 02536455
Manufacturer: Boehringer Ingelheim (Canada) Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-08-26
Issued / Original Publication Date: 2023-06-21
Decision / Authorization Date: 2023-03-22
Updated Date: 2024-06-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1685635290781
Product Type: Drug
Control Number: 267120
DIN(s): 02536080, 02536099, 02536102, 02536110
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-08-19
Issued / Original Publication Date: 2023-05-31
Decision / Authorization Date: 2023-03-10
Updated Date: 2024-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1712172719912
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
Issued / Original Publication Date: 2024-03-28
Decision / Authorization Date: 2023-09-22
Updated Date: 2025-01-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1706623043472
Product Type: Drug
Control Number: 266545
DIN(s): 02539977, 02539985, 02540002, 02540010, 02540029, 02540037, 02540045
Manufacturer: Baxter Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-07-29
Issued / Original Publication Date: 2024-01-26
Decision / Authorization Date: 2023-07-27
Updated Date: 2024-12-04