Review decisions
Showing 230 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00511
Product Type: Drug
Control Number: 244946
DIN(s): 02510014, 02527685
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-10-12
Issued / Original Publication Date: 2021-01-06
Decision / Authorization Date: 2020-12-23
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00510
Product Type: Drug
Control Number: 224906
DIN(s): 02509210, 02522454, 02527863, 02530325
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-10-09
Issued / Original Publication Date: 2020-12-16
Decision / Authorization Date: 2020-12-09
Updated Date: 2024-09-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00498
Product Type: Drug
Control Number: 235295
DIN(s): 02499827, 02499835
Manufacturer: Seattle Genetics Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-10-01
Updated Date: 2022-12-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00519
Product Type: Drug
Control Number: 244627
DIN(s): 02510847, 02511444
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-10-01
Issued / Original Publication Date: 2021-03-05
Decision / Authorization Date: 2021-02-26
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00568
Product Type: Drug
Control Number: 244450
DIN(s): 02520729, 02520737
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-09-25
Issued / Original Publication Date: 2022-01-11
Decision / Authorization Date: 2021-09-23
Updated Date: 2023-08-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00557
Product Type: Drug
Control Number: 244266
DIN(s): 02516233
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-09-22
Issued / Original Publication Date: 2021-11-22
Decision / Authorization Date: 2021-05-26
Updated Date: 2024-01-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00559
Product Type: Drug
Control Number: 243731
DIN(s): 02517590
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-09-10
Issued / Original Publication Date: 2021-11-26
Decision / Authorization Date: 2021-06-30
Updated Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1749640931774
Product Type: Drug
Control Number: 243748
DIN(s): 02516918, 02516926
Manufacturer: Loxo Oncology, Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-09-10
Issued / Original Publication Date: 2021-11-09
Decision / Authorization Date: 2021-06-15
Updated Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00576
Product Type: Drug
Control Number: 242569
DIN(s): 02519933, 02519941, 02519968
Manufacturer: Incyte Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-09-10
Issued / Original Publication Date: 2022-02-16
Decision / Authorization Date: 2021-09-17
Updated Date: 2024-06-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00618
Product Type: Drug
Control Number: 243733
DIN(s): 02530139, 02530147
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-09-09
Issued / Original Publication Date: 2022-12-20
Decision / Authorization Date: 2022-08-31
Updated Date: 2024-11-22