Review decisions

Showing 260 results of 359 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1728318721334
Product Type: Drug
Control Number: 275853
DIN(s): 02544156
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-06-01
Issued / Original Publication Date: 2024-10-06
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1736954230750
Product Type: Drug
Control Number: 275910
DIN(s): 02550970, 02550989
Manufacturer: Accord Healthcare Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-01
Issued / Original Publication Date: 2025-01-15
Decision / Authorization Date: 2024-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1685545138786
Product Type: Drug
Control Number: 264995
DIN(s): 02538164
Manufacturer: Emergent Travel Health Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-06-08
Decision / Authorization Date: 2023-05-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1733496891004
Product Type: Drug
Control Number: 274338
DIN(s): 02550040, 02550059
Manufacturer: Alexion Pharma GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-31
Issued / Original Publication Date: 2024-12-06
Decision / Authorization Date: 2024-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1686583434436
Product Type: Drug
Control Number: 256724
DIN(s): 02480018
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-09-16
Decision / Authorization Date: 2023-06-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1731445138060
Product Type: Drug
Control Number: 275762
Manufacturer: Valneva Austria GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-29
Issued / Original Publication Date: 2024-11-12
Decision / Authorization Date: 2024-11-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722278310406
Product Type: Drug
Control Number: 275576
DIN(s): 02243721, 02531445
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-24
Decision / Authorization Date: 2024-04-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1684415510472
Product Type: Drug
Control Number: 273747
DIN(s): 02532352
Manufacturer: ModernaTX, Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2023-03-29
Decision / Authorization Date: 2023-05-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1687801209635
Product Type: Drug
Control Number: 268412
DIN(s): 02537745
Manufacturer: Rhythm Pharmaceuticals Inc.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-10-04
Decision / Authorization Date: 2023-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1686686460648
Product Type: Drug
Control Number: 264612
DIN(s): 02495155, 02520893
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-27
Decision / Authorization Date: 2023-05-02