Review decisions
Showing 50 results of 56 total
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
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/SBD00408
Product Type: Drug
Control Number: 193890
DIN(s): 02477777
Manufacturer: Pharmacosmos A/S
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-04-28
Issued / Original Publication Date: 2018-11-20
Decision / Authorization Date: 2018-06-22
Updated Date: 2024-07-22
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: 2024-07-22
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00332
Product Type: Drug
Control Number: 189442
DIN(s): 02458136
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-11-12
Issued / Original Publication Date: 2016-10-31
Decision / Authorization Date: 2016-09-28
Updated Date: 2024-06-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00338
Product Type: Drug
Control Number: 187363
DIN(s): 02458640, 02458659, 02458667
Manufacturer: Daiichi Sankyo, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-09-03
Issued / Original Publication Date: 2016-12-21
Decision / Authorization Date: 2016-11-04
Updated Date: 2024-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00327
Product Type: Drug
Control Number: 184993
DIN(s): 02455102, 02455110
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-06-05
Issued / Original Publication Date: 2016-08-02
Decision / Authorization Date: 2016-05-25
Updated Date: 2024-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00211
Product Type: Drug
Control Number: 169414
DIN(s): 02436841, 02497867, 02497875
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2013-10-29
Issued / Original Publication Date: 2015-04-28
Decision / Authorization Date: 2015-01-29
Updated Date: 2024-06-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00271
Product Type: Drug
Control Number: 165665
DIN(s): 02426862, 02426870, 02426889, 02426897
Manufacturer: Sunovion Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2013-06-12
Issued / Original Publication Date: 2014-08-29
Decision / Authorization Date: 2014-07-08
Updated Date: 2024-06-28