Review decisions

Showing 850 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00896
Product Type: Drug
Control Number: 247235
DIN(s): 02522551, 02522578, 02522586, 02522594, 02522608
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-08
Decision / Authorization Date: 2021-11-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00887
Product Type: Drug
Control Number: 257698
DIN(s): 02522454
Manufacturer: BioNTech Manufacturing GmbH. Importer: Pfizer Canada ULC.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2021-10-18
Decision / Authorization Date: 2021-11-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00889
Product Type: Drug
Control Number: 253700
DIN(s): 02510847
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-06-14
Decision / Authorization Date: 2021-11-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00605
Product Type: Drug
Control Number: 258717
DIN(s): 02527588
Manufacturer: Immunocore Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-11-19
Issued / Original Publication Date: 2022-10-03
Decision / Authorization Date: 2022-06-07
Updated Date: 2023-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684173887386
Product Type: Drug
Control Number: 258772
DIN(s): 02532549, 02532557, 02532565, 02532573
Manufacturer: Bristol Myers Squibb Pharma
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-11-18
Issued / Original Publication Date: 2023-04-12
Decision / Authorization Date: 2022-11-08
Updated Date: 2025-05-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00899
Product Type: Drug
Control Number: 247042
DIN(s): 02522403
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-04
Decision / Authorization Date: 2021-11-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01036
Product Type: Drug
Control Number: 246800
DIN(s): 02522446
Manufacturer: Accord Healthcare Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-07
Decision / Authorization Date: 2021-11-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1685714954062
Product Type: Drug
Control Number: 246730
DIN(s): 02522438
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-24
Decision / Authorization Date: 2021-11-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00883
Product Type: Drug
Control Number: 257293
DIN(s): 02510014
Manufacturer: ModernaTX, Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2021-10-06
Decision / Authorization Date: 2021-11-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00891
Product Type: Drug
Control Number: 245680
DIN(s): 02522365
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-10-26
Decision / Authorization Date: 2021-11-12