Review decisions
Showing 20 results of 633 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770219862903
Product Type: Drug
Control Number: 286289
DIN(s): 02525267, 02525275, 02553619, 02553627
Manufacturer: UCB Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-24
Decision / Authorization Date: 2025-12-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770221966795
Product Type: Drug
Control Number: 279522
DIN(s): 02370050, 02370069, 02470489
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-09-28
Decision / Authorization Date: 2025-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1771251043947
Product Type: Drug
Control Number: 296870
DIN(s): 02554283, 02554291, 02565420
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-04-07
Decision / Authorization Date: 2026-02-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770915388549
Product Type: Drug
Control Number: 295692
DIN(s): 02565382
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-02-28
Decision / Authorization Date: 2026-02-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1768234416024
Product Type: Drug
Control Number: 289989
DIN(s): 02536552, 02536560
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-08-30
Decision / Authorization Date: 2025-08-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1767626541718
Product Type: Drug
Control Number: 286477
DIN(s): 02470365, 02492504, 02510049, 02524252
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-30
Decision / Authorization Date: 2025-10-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1766500484485
Product Type: Drug
Control Number: 296767
DIN(s): 02550520, 02550539, 02550547, 02562987, 02562995, 02563002
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-04-02
Decision / Authorization Date: 2025-11-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1766085611036
Product Type: Drug
Control Number: 284571
DIN(s): 02456869
Manufacturer: Merck Canada Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-03-01
Decision / Authorization Date: 2025-07-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765995575445
Product Type: Drug
Control Number: 281626
DIN(s): 02523760, 02523779, 02535076, 02535084, 02556596
Manufacturer: Celltrion Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-30
Decision / Authorization Date: 2025-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765217625791
Product Type: Drug
Control Number: 282235
DIN(s): 00466085
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-12-19
Decision / Authorization Date: 2024-12-03