Review decisions

Showing 1360 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00809
Product Type: Drug
Control Number: 214504
DIN(s): 02491788
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-03-15
Decision / Authorization Date: 2019-08-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00588
Product Type: Drug
Control Number: 220275
DIN(s): 02491753
Manufacturer: ViiV Healthcare ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-09-18
Decision / Authorization Date: 2019-08-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00518
Product Type: Drug
Control Number: 230637
DIN(s): 02502666, 02502674, 02502682
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-08-19
Issued / Original Publication Date: 2021-02-08
Decision / Authorization Date: 2020-10-30
Updated Date: 2024-02-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00545
Product Type: Drug
Control Number: 220039
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-09-10
Decision / Authorization Date: 2019-08-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00516
Product Type: Drug
Control Number: 230825
DIN(s): 02502895
Manufacturer: Elusys Therapeutics, Inc.
Submission Type: Extraordinary Use New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-08-16
Issued / Original Publication Date: 2021-01-28
Decision / Authorization Date: 2020-07-30
Updated Date: 2024-06-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00542
Product Type: Drug
Control Number: 220278
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-09-19
Decision / Authorization Date: 2019-08-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00556
Product Type: Drug
Control Number: 212140
DIN(s): 02483467, 02483475
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-12-15
Decision / Authorization Date: 2019-08-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00543
Product Type: Drug
Control Number: 223862
Manufacturer: Shire Pharmaceuticals Ireland Ltd.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2019-01-18
Decision / Authorization Date: 2019-08-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00541
Product Type: Drug
Control Number: 229124
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-08-12
Issued / Original Publication Date: 2021-07-13
Decision / Authorization Date: 2020-11-24
Updated Date: 2025-01-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00539
Product Type: Drug
Control Number: 211993
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-12-11
Decision / Authorization Date: 2019-08-08