Review decisions

Showing 230 results of 332 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00222
Product Type: Drug
Control Number: 192684
DIN(s): 02461749, 02461757, 02461765, 02461773, 02461781, 02461803
Manufacturer: Otsuka Pharmaceutical Co. Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-02-26
Decision / Authorization Date: 2017-02-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00244
Product Type: Drug
Control Number: 190162
DIN(s): 02460890, 02460904
Manufacturer: Actavis Specialty Pharmaceuticals Co.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-12-11
Decision / Authorization Date: 2017-01-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00388
Product Type: Drug
Control Number: 202059
DIN(s): 02471469, 02471477, 02523930, 02540258
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-01-19
Issued / Original Publication Date: 2018-04-04
Decision / Authorization Date: 2018-01-04
Updated Date: 2024-01-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00208
Product Type: Drug
Control Number: 188323
DIN(s): 02460262, 02460270, 02460289
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-10-23
Decision / Authorization Date: 2017-01-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00212
Product Type: Drug
Control Number: 191280
DIN(s): 02460319
Manufacturer: Biocryst Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-01-25
Decision / Authorization Date: 2017-01-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00262
Product Type: Drug
Control Number: 166949
DIN(s): 02459973, 02459981
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2013-08-23
Decision / Authorization Date: 2016-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00391
Product Type: Drug
Control Number: 201481
DIN(s): 02470624
Manufacturer: GE Healthcare Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-12-22
Issued / Original Publication Date: 2018-04-30
Decision / Authorization Date: 2017-12-07
Updated Date: 2024-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00381
Product Type: Drug
Control Number: 201285
DIN(s): 02470365, 02492504, 02510049, 02524252, 02526190
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-12-16
Issued / Original Publication Date: 2018-02-09
Decision / Authorization Date: 2017-11-30
Updated Date: 2023-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00378
Product Type: Drug
Control Number: 201114
DIN(s): 02470187, 02470268, 02470276, 02532964
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-12-12
Issued / Original Publication Date: 2018-02-02
Decision / Authorization Date: 2017-11-29
Updated Date: 2024-02-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00203
Product Type: Drug
Control Number: 186333
DIN(s): 02459329
Manufacturer: Guerbet
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-07-31
Decision / Authorization Date: 2016-11-26