Review decisions
Showing 420 results of 2299 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00969
Product Type: Drug
Control Number: 263775
Manufacturer: ModernaTX, Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-04-29
Decision / Authorization Date: 2022-07-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01019
Product Type: Drug
Control Number: 240368
Manufacturer: Kye Pharmaceuticals Inc., Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-18
Decision / Authorization Date: 2022-07-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00596
Product Type: Drug
Control Number: 251687
DIN(s): 02526247, 02526255, 02526263
Manufacturer: BioMarin International Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-07-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01061
Product Type: Drug
Control Number: 254495
DIN(s): 02528908
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-07-09
Decision / Authorization Date: 2022-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00594
Product Type: Drug
Control Number: 254440
DIN(s): 02526182
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00973
Product Type: Drug
Control Number: 259725
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-20
Decision / Authorization Date: 2022-07-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00595
Product Type: Drug
Control Number: 245791
DIN(s): 02526115
Manufacturer: Kadmon Pharmaceuticals LLC
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-07-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00971
Product Type: Drug
Control Number: 259703
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-17
Decision / Authorization Date: 2022-07-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00609
Product Type: Drug
Control Number: 265656
DIN(s): 02530252
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-06-30
Issued / Original Publication Date: 2022-10-27
Decision / Authorization Date: 2022-09-01
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01102
Product Type: Drug
Control Number: 245854
DIN(s): 02528363, 02528371, 02528398
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-10-29
Decision / Authorization Date: 2022-06-29