Review decisions

Showing 320 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00407
Product Type: Drug
Control Number: 212276
DIN(s): 02478765
Manufacturer: Recordati Rare Diseases Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2018-11-20
Updated Date: 2020-02-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00564
Product Type: Drug
Control Number: 222001
DIN(s): 02518112
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-11-19
Issued / Original Publication Date: 2021-12-08
Decision / Authorization Date: 2021-07-16
Updated Date: 2024-06-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00446
Product Type: Drug
Control Number: 221896
DIN(s): 02489252
Manufacturer: Alnylam Pharmaceuticals
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-11-14
Issued / Original Publication Date: 2019-10-02
Decision / Authorization Date: 2019-06-07
Updated Date: 2025-03-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00535
Product Type: Drug
Control Number: 217314
DIN(s): 02492156, 02492164, 02505258
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-10-01
Issued / Original Publication Date: 2021-06-10
Decision / Authorization Date: 2020-11-04
Updated Date: 2023-08-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00460
Product Type: Drug
Control Number: 215288
DIN(s): 02493012
Manufacturer: Cipher Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-09-20
Issued / Original Publication Date: 2020-01-27
Decision / Authorization Date: 2019-10-10
Updated Date: 2024-06-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00455
Product Type: Drug
Control Number: 219998
DIN(s): 02490315, 02490323, 02490331
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2018-09-18
Issued / Original Publication Date: 2019-12-18
Decision / Authorization Date: 2019-07-10
Updated Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00463
Product Type: Drug
Control Number: 217955
DIN(s): 02491559, 02533448, 02533456
Manufacturer: Alexion Pharma Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-09-13
Issued / Original Publication Date: 2020-03-02
Decision / Authorization Date: 2019-08-28
Updated Date: 2025-09-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00454
Product Type: Drug
Control Number: 219521
DIN(s): 02491060, 02491087, 02505134
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-08-21
Issued / Original Publication Date: 2019-12-20
Decision / Authorization Date: 2019-07-30
Updated Date: 2025-07-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00468
Product Type: Drug
Control Number: 218799
DIN(s): 02490714, 02490722
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-08-15
Issued / Original Publication Date: 2020-03-12
Decision / Authorization Date: 2019-07-25
Updated Date: 2025-05-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00443
Product Type: Drug
Control Number: 218718
DIN(s): 02487144, 02487152
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2018-07-27
Issued / Original Publication Date: 2019-08-27
Decision / Authorization Date: 2019-04-10
Updated Date: 2024-12-06