Review decisions
Showing 170 results of 332 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00658
Product Type: Drug
Control Number: 218224
DIN(s): 02490536
Manufacturer: Puma Biotechnology Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-07-19
Decision / Authorization Date: 2019-07-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00763
Product Type: Drug
Control Number: 217663
DIN(s): 02490366
Manufacturer: Otsuka Pharmaceutical Co. Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-06-29
Decision / Authorization Date: 2019-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00509
Product Type: Drug
Control Number: 229245
DIN(s): 02498235, 02498243
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-06-28
Issued / Original Publication Date: 2020-12-08
Decision / Authorization Date: 2020-04-29
Updated Date: 2024-09-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00657
Product Type: Drug
Control Number: 216792
DIN(s): 02489783
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-06-04
Decision / Authorization Date: 2019-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00551
Product Type: Drug
Control Number: 206099
DIN(s): 02488361
Manufacturer: Biosyent Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-06-01
Decision / Authorization Date: 2019-05-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00479
Product Type: Drug
Control Number: 226828
DIN(s): 02497859, 02509474
Manufacturer: Teva Canada Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-05-01
Issued / Original Publication Date: 2020-06-15
Decision / Authorization Date: 2020-04-09
Updated Date: 2024-02-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00475
Product Type: Drug
Control Number: 227361
DIN(s): 02496364, 02496372, 02524163
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-04-30
Issued / Original Publication Date: 2020-05-05
Decision / Authorization Date: 2020-02-19
Updated Date: 2023-08-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00671
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
Decision / Authorization Date: 2019-04-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00482
Product Type: Drug
Control Number: 226146
DIN(s): 02496348
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-03-27
Issued / Original Publication Date: 2020-06-29
Decision / Authorization Date: 2020-02-20
Updated Date: 2023-08-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00489
Product Type: Drug
Control Number: 226224
DIN(s): 02496976, 02496984
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-03-27
Issued / Original Publication Date: 2020-08-04
Decision / Authorization Date: 2020-03-12
Updated Date: 2024-04-10