Review decisions
Showing 280 results of 359 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1728656969053
Product Type: Drug
Control Number: 274859
DIN(s): 02544733, 02544741
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-28
Issued / Original Publication Date: 2024-10-11
Decision / Authorization Date: 2024-01-26
Updated Date: 2025-06-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1685721892425
Product Type: Drug
Control Number: 263700
DIN(s): 02487144, 02487152
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-04-26
Decision / Authorization Date: 2023-04-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1730227073967
Product Type: Drug
Control Number: 274598
DIN(s): 02548909
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-21
Issued / Original Publication Date: 2024-10-29
Decision / Authorization Date: 2024-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1684435400131
Product Type: Drug
Control Number: 267878
DIN(s): 02347113, 02347121, 02347148, 02365669, 02417103, 02417111, 02417138, 02417146
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-09-14
Decision / Authorization Date: 2023-03-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683570485222
Product Type: Drug
Control Number: 263638
DIN(s): 02537117
Manufacturer: Advanced Accelerator Application USA, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-04-22
Decision / Authorization Date: 2023-04-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683571472631
Product Type: Drug
Control Number: 266965
DIN(s): 02490315, 02490323, 02490331
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-08-12
Decision / Authorization Date: 2023-03-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683639670276
Product Type: Drug
Control Number: 261912
DIN(s): 02436523, 02436531, 02436558, 02536579
Manufacturer: Chiesi Canada Corp.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-01
Decision / Authorization Date: 2023-03-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1749475835167
Product Type: Drug
Control Number: 272063
DIN(s): 02448254
Manufacturer: Dermavant Sciences, GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Issued / Original Publication Date: 2025-06-07
Decision / Authorization Date: 2025-04-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734642660051
Product Type: Drug
Control Number: 273850
DIN(s): 02546205, 02546213, 02546221
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Issued / Original Publication Date: 2024-12-18
Decision / Authorization Date: 2024-03-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1722604848949
Product Type: Drug
Control Number: 273908
DIN(s): 02544555, 02544563, 02544571
Manufacturer: Amryt Pharmaceuticals DAC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-03-31
Issued / Original Publication Date: 2024-08-01
Decision / Authorization Date: 2024-01-17
Updated Date: 2025-01-21