Review decisions

Showing 200 results of 332 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00420
Product Type: Drug
Control Number: 206906
DIN(s): 02476991
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-06-23
Decision / Authorization Date: 2018-06-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00450
Product Type: Drug
Control Number: 216792
DIN(s): 02489783, 02530031
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-06-04
Issued / Original Publication Date: 2019-11-19
Decision / Authorization Date: 2019-06-27
Updated Date: 2024-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00404
Product Type: Drug
Control Number: 204724
DIN(s): 02475510, 02475529
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-04-13
Decision / Authorization Date: 2018-05-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00444
Product Type: Drug
Control Number: 215753
DIN(s): 02487454, 02519283, 02519291, 02532093, 02532107, 02546922
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-05-07
Issued / Original Publication Date: 2019-09-26
Decision / Authorization Date: 2019-04-17
Updated Date: 2024-09-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00445
Product Type: Drug
Control Number: 215268
DIN(s): 02487098, 02487101, 02487128, 02487136
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-04-16
Issued / Original Publication Date: 2019-09-26
Decision / Authorization Date: 2019-04-05
Updated Date: 2024-11-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00352
Product Type: Drug
Control Number: 203884
DIN(s): 02473569
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-03-17
Decision / Authorization Date: 2018-03-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00348
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
Decision / Authorization Date: 2018-02-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00370
Product Type: Drug
Control Number: 198689
Manufacturer: Eisai Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-09-27
Decision / Authorization Date: 2018-02-02
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: 2023-08-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00419
Product Type: Drug
Control Number: 201492
DIN(s): 02471574
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-12-22
Decision / Authorization Date: 2018-01-05