Review decisions

Showing 220 results of 332 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00412
Product Type: Drug
Control Number: 208607
DIN(s): 02479605, 02479613, 02487292, 02487306
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-08-18
Issued / Original Publication Date: 2018-12-19
Decision / Authorization Date: 2018-08-01
Updated Date: 2024-10-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00405
Product Type: Drug
Control Number: 203718
DIN(s): 02478579
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-07-26
Issued / Original Publication Date: 2018-10-17
Decision / Authorization Date: 2018-07-10
Updated Date: 2024-08-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00259
Product Type: Drug
Control Number: 193862
DIN(s): 02464276, 02464284, 02464349
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-04-26
Decision / Authorization Date: 2017-05-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00409
Product Type: Drug
Control Number: 205392
DIN(s): 02478498
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-05-09
Issued / Original Publication Date: 2018-11-27
Decision / Authorization Date: 2018-07-10
Updated Date: 2024-06-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00238
Product Type: Drug
Control Number: 183050
DIN(s): 02463261
Manufacturer: Sanofi Genzyme, A Division of Sanofi-aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-03-19
Decision / Authorization Date: 2017-04-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00403
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
Issued / Original Publication Date: 2018-10-01
Decision / Authorization Date: 2018-05-09
Updated Date: 2023-07-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00231
Product Type: Drug
Control Number: 189825
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-11-23
Decision / Authorization Date: 2017-03-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00390
Product Type: Drug
Control Number: 204008
DIN(s): 02473232, 02496135
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-03-21
Issued / Original Publication Date: 2018-04-30
Decision / Authorization Date: 2018-02-22
Updated Date: 2023-09-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00237
Product Type: Drug
Control Number: 190817
DIN(s): 02462400
Manufacturer: Cardiome UK Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-01-04
Decision / Authorization Date: 2017-03-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00418
Product Type: Drug
Control Number: 210368
DIN(s): 02481359, 02481367, 02481375
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-02-20
Issued / Original Publication Date: 2019-02-11
Decision / Authorization Date: 2018-10-03
Updated Date: 2024-08-16