Review decisions
Showing 350 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00422
Product Type: Drug
Control Number: 214274
DIN(s): 02481383
Manufacturer: Akcea Therapeutics, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-03-07
Issued / Original Publication Date: 2019-03-11
Decision / Authorization Date: 2018-10-03
Updated Date: 2025-03-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00494
Product Type: Drug
Control Number: 214058
DIN(s): 02498316
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-03-06
Issued / Original Publication Date: 2020-09-02
Decision / Authorization Date: 2020-04-28
Updated Date: 2025-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00486
Product Type: Drug
Control Number: 214080
DIN(s): 02485575, 02485583, 02485591, 02485656
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-02-28
Issued / Original Publication Date: 2020-07-30
Decision / Authorization Date: 2020-04-16
Updated Date: 2024-08-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00420
Product Type: Drug
Control Number: 213920
DIN(s): 02480948, 02505614
Manufacturer: Shire Pharma Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-02-22
Issued / Original Publication Date: 2019-02-18
Decision / Authorization Date: 2018-09-19
Updated Date: 2024-08-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00380
Product Type: Drug
Control Number: 203478
DIN(s): 02469227
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2018-02-09
Updated Date: 2021-11-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00416
Product Type: Drug
Control Number: 213547
DIN(s): 02480514
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-02-09
Issued / Original Publication Date: 2019-02-08
Decision / Authorization Date: 2018-09-05
Updated Date: 2025-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00434
Product Type: Drug
Control Number: 213188
DIN(s): 02484420, 02484439
Manufacturer: Shire Pharma Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-01-26
Issued / Original Publication Date: 2019-06-18
Decision / Authorization Date: 2019-01-10
Updated Date: 2025-09-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00411
Product Type: Drug
Control Number: 212635
DIN(s): 02479621, 02479648, 02479656, 02479664
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-01-08
Issued / Original Publication Date: 2018-12-18
Decision / Authorization Date: 2018-08-02
Updated Date: 2023-03-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00436
Product Type: Drug
Control Number: 207372
DIN(s): 02484811
Manufacturer: Pendopharm, Division of Pharmascience Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-12-28
Issued / Original Publication Date: 2019-06-25
Decision / Authorization Date: 2019-01-21
Updated Date: 2022-12-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00413
Product Type: Drug
Control Number: 212390
DIN(s): 02480522
Manufacturer: Cipher Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-12-21
Issued / Original Publication Date: 2019-01-08
Decision / Authorization Date: 2018-09-04
Updated Date: 2025-07-29