Review decisions
Showing 520 results of 1549 total
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/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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00988
Product Type: Drug
Control Number: 255495
DIN(s): 02530163, 02530171
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-08-05
Decision / Authorization Date: 2022-08-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00991
Product Type: Drug
Control Number: 260951
DIN(s): 02530198
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-01-28
Decision / Authorization Date: 2022-08-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00999
Product Type: Drug
Control Number: 259448
DIN(s): 02530031
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-11-10
Decision / Authorization Date: 2022-08-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00983
Product Type: Drug
Control Number: 264621
DIN(s): 02522454
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-05-27
Decision / Authorization Date: 2022-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00990
Product Type: Drug
Control Number: 261300
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-02-08
Decision / Authorization Date: 2022-08-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01069
Product Type: Drug
Control Number: 256537
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-09-09
Decision / Authorization Date: 2022-08-18