Review decisions
Showing 890 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00855
Product Type: Drug
Control Number: 252733
DIN(s): 02510014
Manufacturer: ModernaTX, Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-06-15
Decision / Authorization Date: 2021-09-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00856
Product Type: Drug
Control Number: 252736
DIN(s): 02509210
Manufacturer: BioNTech Manufacturing GmbH. Importer: Pfizer Canada ULC.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-06-10
Decision / Authorization Date: 2021-09-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00865
Product Type: Drug
Control Number: 252448
Manufacturer: Canadian Blood Services
Submission Type: Application for an Authorization Amendment
Date Filed / Submission Date: 2021-05-06
Decision / Authorization Date: 2021-09-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00863
Product Type: Drug
Control Number: 244611
DIN(s): 02520184, 02520192, 02520206, 02520214, 02520222, 02520230
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-09-30
Decision / Authorization Date: 2021-09-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00861
Product Type: Drug
Control Number: 244472
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-10-07
Decision / Authorization Date: 2021-09-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00860
Product Type: Drug
Control Number: 244601
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-10-01
Decision / Authorization Date: 2021-09-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00881
Product Type: Drug
Control Number: 248435
DIN(s): 02520095
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-14
Decision / Authorization Date: 2021-09-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00893
Product Type: Drug
Control Number: 244618
Manufacturer: Sandoz Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-10-01
Decision / Authorization Date: 2021-09-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00615
Product Type: Drug
Control Number: 254548
DIN(s): 02529688
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-09-10
Issued / Original Publication Date: 2022-12-16
Decision / Authorization Date: 2022-08-16
Updated Date: 2023-08-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00895
Product Type: Drug
Control Number: 244338
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-09-23
Decision / Authorization Date: 2021-09-02