Review decisions
Showing 450 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00362
Product Type: Drug
Control Number: 191347
DIN(s): 02464705, 02464713
Manufacturer: Horizon Pharma Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2016-01-21
Issued / Original Publication Date: 2017-08-21
Decision / Authorization Date: 2017-06-13
Updated Date: 2025-07-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00343
Product Type: Drug
Control Number: 190891
DIN(s): 02459531, 02459558, 02459566, 02459574, 02459582, 02459590, 02459604
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-12-23
Issued / Original Publication Date: 2017-02-17
Decision / Authorization Date: 2016-12-12
Updated Date: 2025-01-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00351
Product Type: Drug
Control Number: 190645
Manufacturer: Cangene Corporation
Submission Type: Extraordinary Use New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-12-22
Issued / Original Publication Date: 2017-04-12
Decision / Authorization Date: 2016-12-08
Updated Date: 2024-01-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00339
Product Type: Drug
Control Number: 190761
DIN(s): 02458039, 02458047, 02458055, 02458063
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-12-18
Issued / Original Publication Date: 2016-12-22
Decision / Authorization Date: 2016-09-30
Updated Date: 2023-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00334
Product Type: Drug
Control Number: 190498
DIN(s): 02456796, 02456818, 02456826
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-12-14
Issued / Original Publication Date: 2016-10-21
Decision / Authorization Date: 2016-08-04
Updated Date: 2025-03-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00538
Product Type: Drug
Control Number: 190433
DIN(s): 02459299, 02459302, 02459310
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-12-11
Issued / Original Publication Date: 2021-07-08
Decision / Authorization Date: 2020-11-04
Updated Date: 2024-02-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00346
Product Type: Drug
Control Number: 190162
DIN(s): 02460890, 02460904
Manufacturer: Allergan Pharma Co.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-12-11
Issued / Original Publication Date: 2017-03-01
Decision / Authorization Date: 2017-01-26
Updated Date: 2025-08-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00393
Product Type: Drug
Control Number: 188743
DIN(s): 02487462, 02487470, 02487489
Manufacturer: Ferring Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-12-09
Issued / Original Publication Date: 2018-06-02
Decision / Authorization Date: 2018-03-22
Updated Date: 2024-11-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00340
Product Type: Drug
Control Number: 189709
DIN(s): 02459035, 02459043, 02459051, 02459078, 02498537, 02498545, 02498553, 02498561, 02498588, 02498596, 02498618, 02498626
Manufacturer: Baxalta Canada Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-12-02
Issued / Original Publication Date: 2016-12-30
Decision / Authorization Date: 2016-11-17
Updated Date: 2023-11-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00392
Product Type: Drug
Control Number: 189352
DIN(s): 02473550
Manufacturer: Sprout Pharmaceuticals, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-11-18
Issued / Original Publication Date: 2018-05-03
Decision / Authorization Date: 2018-02-27
Updated Date: 2024-07-05