Review decisions
Showing 390 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00373
Product Type: Drug
Control Number: 204165
DIN(s): 02469367, 02469375, 02469383, 02469405
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-04-10
Issued / Original Publication Date: 2018-06-04
Decision / Authorization Date: 2017-11-01
Updated Date: 2025-07-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00350
Product Type: Drug
Control Number: 188323
DIN(s): 02460262, 02460270, 02460289
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-04-03
Updated Date: 2019-12-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00399
Product Type: Drug
Control Number: 204077
DIN(s): 02473909
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-03-30
Issued / Original Publication Date: 2018-08-22
Decision / Authorization Date: 2018-03-15
Updated Date: 2025-08-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00382
Product Type: Drug
Control Number: 204085
DIN(s): 02469596
Manufacturer: Alexion Pharma GmbH
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2017-03-23
Issued / Original Publication Date: 2018-02-09
Decision / Authorization Date: 2017-12-15
Updated Date: 2023-11-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00385
Product Type: Drug
Control Number: 204052
DIN(s): 02469723
Manufacturer: EMD Serono, A division of EMD Inc. Canada
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2017-03-23
Issued / Original Publication Date: 2018-03-09
Decision / Authorization Date: 2017-12-08
Updated Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00390
Product Type: Drug
Control Number: 204008
DIN(s): 02473232, 02496135
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-03-21
Issued / Original Publication Date: 2018-04-30
Decision / Authorization Date: 2018-02-22
Updated Date: 2023-09-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00395
Product Type: Drug
Control Number: 203884
DIN(s): 02473569
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-03-17
Issued / Original Publication Date: 2018-06-18
Decision / Authorization Date: 2018-03-02
Updated Date: 2024-12-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00349
Product Type: Drug
Control Number: 191280
DIN(s): 02460319
Manufacturer: BioCryst Pharmaceuticals, Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-03-07
Updated Date: 2018-11-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00348
Product Type: Drug
Control Number: 166949
DIN(s): 02459973, 02459981
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-03-06
Updated Date: 2019-03-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00398
Product Type: Drug
Control Number: 203250, 203292
DIN(s): 02473097, 02473100, 02533472, 02533480
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-03-02
Issued / Original Publication Date: 2018-08-20
Decision / Authorization Date: 2018-05-08
Updated Date: 2024-07-05