Review decisions

Showing 10 results of 244 total
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/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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1768236073374
Product Type: Drug
Control Number: 280995
DIN(s): 00297763, 02555093
Manufacturer: Marcan Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-10
Decision / Authorization Date: 2025-02-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764967113004
Product Type: Drug
Control Number: 279915
DIN(s): 02522551, 02522578, 02522586, 02522594, 02522608, 02528509, 02528517, 02528525, 02528533, 02528541, 02552698
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-13
Decision / Authorization Date: 2024-11-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1772730117045
Product Type: Drug
Control Number: 282015
DIN(s): 02560704
Manufacturer: Leo Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-12-13
Decision / Authorization Date: 2025-08-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1762525671043
Product Type: Drug
Control Number: 262828
DIN(s): 02323273
Manufacturer: Galderma Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-28
Decision / Authorization Date: 2023-02-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764950027991
Product Type: Drug
Control Number: 281695
DIN(s): 02552965, 02552973, 02552981
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-30
Decision / Authorization Date: 2024-11-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764698444664
Product Type: Drug
Control Number: 275803
DIN(s): 02551454, 02551462
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-14
Decision / Authorization Date: 2024-09-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765982892086
Product Type: Drug
Control Number: 276541
Manufacturer: Takeda Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-06-23
Decision / Authorization Date: 2025-03-13