Review decisions
Showing 410 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00364
Product Type: Drug
Control Number: 200808
DIN(s): 02465981
Manufacturer: Jazz Pharmaceuticals Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2016-12-09
Issued / Original Publication Date: 2017-09-08
Decision / Authorization Date: 2017-07-10
Updated Date: 2025-07-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00365
Product Type: Drug
Control Number: 201101
DIN(s): 02466236
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2016-12-09
Issued / Original Publication Date: 2017-09-27
Decision / Authorization Date: 2017-07-21
Updated Date: 2025-11-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00432
Product Type: Drug
Control Number: 200807
DIN(s): 02484153
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-12-05
Issued / Original Publication Date: 2019-05-29
Decision / Authorization Date: 2018-12-24
Updated Date: 2024-04-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00374
Product Type: Drug
Control Number: 200792
DIN(s): 02469871, 02469898, 02469901
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-11-30
Issued / Original Publication Date: 2017-12-28
Decision / Authorization Date: 2017-11-16
Updated Date: 2023-10-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00387
Product Type: Drug
Control Number: 200590
DIN(s): 02469758, 02487314
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-11-25
Issued / Original Publication Date: 2018-03-23
Decision / Authorization Date: 2017-11-10
Updated Date: 2024-08-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00376
Product Type: Drug
Control Number: 200446
DIN(s): 02469588
Manufacturer: Emergent BioSolutions Canada Inc.
Submission Type: Extraordinary Use New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-11-24
Issued / Original Publication Date: 2018-01-11
Decision / Authorization Date: 2017-11-06
Updated Date: 2024-01-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00336
Product Type: Drug
Control Number: 190564
DIN(s): 02457717, 02457725, 02457733, 02470055
Manufacturer: Mendelikabs Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-11-18
Updated Date: 2020-10-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00377
Product Type: Drug
Control Number: 200244
DIN(s): 02468425
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-11-17
Issued / Original Publication Date: 2018-01-15
Decision / Authorization Date: 2017-10-13
Updated Date: 2024-08-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00361
Product Type: Drug
Control Number: 200070
DIN(s): 02465663
Manufacturer: Biogen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2016-11-10
Issued / Original Publication Date: 2017-08-15
Decision / Authorization Date: 2017-06-29
Updated Date: 2025-06-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00383
Product Type: Drug
Control Number: 199810
DIN(s): 02471027
Manufacturer: Shire Pharma Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-10-28
Issued / Original Publication Date: 2018-02-20
Decision / Authorization Date: 2017-12-22
Updated Date: 2025-07-24