Review decisions
Showing 240 results of 332 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00387
Product Type: Drug
Control Number: 200590
DIN(s): 02469758, 02487314
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-11-25
Issued / Original Publication Date: 2018-03-23
Decision / Authorization Date: 2017-11-10
Updated Date: 2024-08-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00377
Product Type: Drug
Control Number: 200244
DIN(s): 02468425
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-11-17
Issued / Original Publication Date: 2018-01-15
Decision / Authorization Date: 2017-10-13
Updated Date: 2024-08-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00248
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
Decision / Authorization Date: 2016-11-04
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/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/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/RDS00154
Product Type: Drug
Control Number: 179294
DIN(s): 02456532
Manufacturer: Bausch and Lomb, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-08-19
Decision / Authorization Date: 2016-07-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00162
Product Type: Drug
Control Number: 186488
DIN(s): 02456451, 02456478
Manufacturer: Pediapharm Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-08-04
Decision / Authorization Date: 2016-07-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00372
Product Type: Drug
Control Number: 196956
DIN(s): 02468042
Manufacturer: Amicus Therapeutics UK Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-07-15
Issued / Original Publication Date: 2017-12-13
Decision / Authorization Date: 2017-09-05
Updated Date: 2023-08-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00431
Product Type: Drug
Control Number: 196367
DIN(s): 02483505
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-07-05
Issued / Original Publication Date: 2019-05-16
Decision / Authorization Date: 2018-11-29
Updated Date: 2023-02-28