Review decisions
Showing 380 results of 2299 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01002
Product Type: Drug
Control Number: 257092
DIN(s): 02530406
Manufacturer: Jazz Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-09-27
Decision / Authorization Date: 2022-09-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00612
Product Type: Drug
Control Number: 267502
DIN(s): 02531461, 02533197, 02541025
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-09-02
Issued / Original Publication Date: 2022-12-05
Decision / Authorization Date: 2022-10-07
Updated Date: 2024-09-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00987
Product Type: Drug
Control Number: 265656
DIN(s): 02530252
Manufacturer: ModernaTX, Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-06-30
Decision / Authorization Date: 2022-09-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00992
Product Type: Drug
Control Number: 234562
DIN(s): 02530287, 02530295, 02530309
Manufacturer: Lupin Pharma Canada Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-12-19
Decision / Authorization Date: 2022-08-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01005
Product Type: Drug
Control Number: 243733
DIN(s): 02530139, 02530147
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-09-09
Decision / Authorization Date: 2022-08-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00603
Product Type: Drug
Control Number: 253111
DIN(s): 02527049
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-08-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00602
Product Type: Drug
Control Number: 255972
DIN(s): 02527391, 02527405
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-08-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1709043672605
Product Type: Drug
Control Number: 267438
DIN(s): 02541599
Manufacturer: Argenx BV
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-29
Issued / Original Publication Date: 2024-02-24
Decision / Authorization Date: 2023-09-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1700071951489
Product Type: Drug
Control Number: 267443
DIN(s): 02539934, 02539942, 02539950
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-29
Issued / Original Publication Date: 2023-11-15
Decision / Authorization Date: 2023-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00994
Product Type: Drug
Control Number: 254518
Manufacturer: Vaccigen Ltd.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-02-14
Decision / Authorization Date: 2022-08-26