Review decisions

Showing 390 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708462789662
Product Type: Drug
Control Number: 266553
DIN(s): 02544334, 02544342
Manufacturer: B. Braun Medical Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-08-22
Decision / Authorization Date: 2024-01-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708532368148
Product Type: Drug
Control Number: 272746
DIN(s): 02545004
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-24
Decision / Authorization Date: 2024-02-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708351809911
Product Type: Drug
Control Number: 258157
DIN(s): 02543745
Manufacturer: Xediton Pharmaceuticals
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-10-29
Decision / Authorization Date: 2023-12-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1712323528783
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
Decision / Authorization Date: 2023-12-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1707836185816
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
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1747748736412
Product Type: Drug
Control Number: 283753
DIN(s): 02447967, 02448114, 02448122, 02448130, 02448149, 02448157
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-02-09
Issued / Original Publication Date: 2025-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1707157428464
DIN(s): 02453150, 02453169, 02453177, 02493535, 02493543, 02493551
Issued / Original Publication Date: 2024-02-09
Updated Date: 2024-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1707495404187
Product Type: Drug
Control Number: 272409
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-14
Decision / Authorization Date: 2024-02-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710793698140
Product Type: Drug
Control Number: 269884
DIN(s): 02524481, 02545012
Manufacturer: Avir Pharma Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-11-18
Decision / Authorization Date: 2024-02-05
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