Review decisions
Showing 660 results of 1550 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01070
Product Type: Drug
Control Number: 220887
Manufacturer: Acerus Pharmaceuticals Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-03-08
Decision / Authorization Date: 2021-10-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00958
Product Type: Drug
Control Number: 250213
DIN(s): 02520869
Manufacturer: ViiV Healthcare ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-03-05
Decision / Authorization Date: 2021-10-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00866
Product Type: Drug
Control Number: 248753
DIN(s): 02520788
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2021-01-25
Decision / Authorization Date: 2021-09-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00864
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
Decision / Authorization Date: 2021-09-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00892
Product Type: Drug
Control Number: 242395
Manufacturer: Centus Biotherapeutics Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-08-20
Decision / Authorization Date: 2021-09-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00880
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
Decision / Authorization Date: 2021-09-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00875
Product Type: Drug
Control Number: 250805
Manufacturer: CytoDyn Inc.
Submission Type: Application filed under section 3 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2021-03-22
Decision / Authorization Date: 2021-09-16
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