Review decisions

Showing 320 results of 2270 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00610
Product Type: Drug
Control Number: 252301
DIN(s): 02527693
Manufacturer: BioCryst Pharmaceuticals, Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-10-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01009
Product Type: Drug
Control Number: 265382
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-06-22
Decision / Authorization Date: 2022-10-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01041
Product Type: Drug
Control Number: 256308
DIN(s): 02488078, 02488086, 02488094
Manufacturer: Verity Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-09-03
Decision / Authorization Date: 2022-10-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1721405092068
Product Type: Drug
Control Number: 268723
DIN(s): 02543532
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-14
Issued / Original Publication Date: 2024-07-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01008
Product Type: Drug
Control Number: 261220
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-02-04
Decision / Authorization Date: 2022-10-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01017
Product Type: Drug
Control Number: 242332
DIN(s): 02531836
Manufacturer: Telix Pharmaceuticals (US) Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-06
Decision / Authorization Date: 2022-10-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01011
Product Type: Drug
Control Number: 258126
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-10-29
Decision / Authorization Date: 2022-10-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01010
Product Type: Drug
Control Number: 258009
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-10-26
Decision / Authorization Date: 2022-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01018
Product Type: Drug
Control Number: 258125
Manufacturer: Sandoz Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-10-28
Decision / Authorization Date: 2022-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01093
Product Type: Drug
Control Number: 257242
DIN(s): 02531593, 02531607, 02531615
Manufacturer: Auro Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-11-29
Decision / Authorization Date: 2022-10-11