Review decisions

Showing 420 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00466
Product Type: Drug
Control Number: 198822
DIN(s): 02493500
Manufacturer: Endoceutics, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-10-05
Issued / Original Publication Date: 2020-03-10
Decision / Authorization Date: 2019-11-01
Updated Date: 2025-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00375
Product Type: Drug
Control Number: 196495
DIN(s): 02468735
Manufacturer: Purdue Pharma
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-10-03
Issued / Original Publication Date: 2018-01-10
Decision / Authorization Date: 2017-09-28
Updated Date: 2024-06-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00328
Product Type: Drug
Control Number: 188171
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-09-22
Updated Date: 2022-10-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00366
Product Type: Drug
Control Number: 198094
DIN(s): 02467224
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-09-16
Issued / Original Publication Date: 2017-10-19
Decision / Authorization Date: 2017-08-14
Updated Date: 2024-02-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00357
Product Type: Drug
Control Number: 198418
DIN(s): 02463121, 02463148
Manufacturer: Intercept Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2016-09-16
Issued / Original Publication Date: 2017-06-21
Decision / Authorization Date: 2017-05-24
Updated Date: 2025-05-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00369
Product Type: Drug
Control Number: 198124
DIN(s): 02467860, 02467879, 02467887
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-09-13
Issued / Original Publication Date: 2017-11-28
Decision / Authorization Date: 2017-08-25
Updated Date: 2024-02-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00324
Product Type: Drug
Control Number: 179294
DIN(s): 02456532
Manufacturer: Bausch and Lomb, Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-09-07
Updated Date: 2017-06-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00451
Product Type: Drug
Control Number: 197713
DIN(s): 02489597
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-08-18
Issued / Original Publication Date: 2019-11-21
Decision / Authorization Date: 2019-06-17
Updated Date: 2025-07-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00322
Product Type: Drug
Control Number: 182503
DIN(s): 02454343
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-08-08
Updated Date: 2020-12-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00319
Product Type: Drug
Control Number: 179320
DIN(s): 02454815
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-07-18
Updated Date: 2022-11-25