Review decisions

Showing 1100 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00740
Product Type: Drug
Control Number: 234113
Manufacturer: Seqirus UK Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-12-12
Decision / Authorization Date: 2020-11-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00747
Product Type: Drug
Control Number: 234438
Manufacturer: Merz Pharmaceuticals GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-19
Decision / Authorization Date: 2020-11-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00721
Product Type: Drug
Control Number: 234406
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-13
Decision / Authorization Date: 2020-11-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00563
Product Type: Drug
Control Number: 246355
DIN(s): 02516667, 02532719
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-11-13
Issued / Original Publication Date: 2021-12-06
Decision / Authorization Date: 2021-06-08
Updated Date: 2025-03-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00727
Product Type: Drug
Control Number: 234105
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-02
Decision / Authorization Date: 2020-11-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00774
Product Type: Drug
Control Number: 237994
DIN(s): 02507587
Manufacturer: Sandoz Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-03-31
Decision / Authorization Date: 2020-11-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00575
Product Type: Drug
Control Number: 246187
DIN(s): 02522845
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-11-09
Issued / Original Publication Date: 2022-02-08
Decision / Authorization Date: 2021-11-30
Updated Date: 2025-10-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00768
Product Type: Drug
Control Number: 233923
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-11-28
Decision / Authorization Date: 2020-11-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00808
Product Type: Drug
Control Number: 227936
DIN(s): 02439360
Manufacturer: Recordati Rare Diseases Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2019-05-17
Decision / Authorization Date: 2020-11-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00720
Product Type: Drug
Control Number: 233914
Manufacturer: Bavarian Nordic AS
Submission Type: Supplement to an Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2019-11-19
Decision / Authorization Date: 2020-11-05