Review decisions
Showing 920 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00703
Product Type: Drug
Control Number: 220505
DIN(s): 02495597, 02495600, 02495619
Manufacturer: Mylan Pharmaceuticals ULC
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2018-09-27
Decision / Authorization Date: 2020-01-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00663
Product Type: Drug
Control Number: 228368
DIN(s): 02495732
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-06-03
Decision / Authorization Date: 2020-01-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1685716255549
Product Type: Drug
Control Number: 235219
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-01-16
Decision / Authorization Date: 2021-01-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00608
Product Type: Drug
Control Number: 215409
DIN(s): 02495589
Manufacturer: Avir Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-04-12
Decision / Authorization Date: 2020-01-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00662
Product Type: Drug
Control Number: 227235
DIN(s): 02495244
Manufacturer: HLS Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-04-29
Decision / Authorization Date: 2019-12-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00760
Product Type: Drug
Control Number: 223734
DIN(s): 02495155
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-01-16
Decision / Authorization Date: 2019-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00807
Product Type: Drug
Control Number: 227918
DIN(s): 02495058
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-05-22
Decision / Authorization Date: 2019-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00597
Product Type: Drug
Control Number: 210780
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-10-30
Decision / Authorization Date: 2019-12-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00607
Product Type: Drug
Control Number: 227404
DIN(s): 02494760, 02494779
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-05-03
Decision / Authorization Date: 2019-12-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00620
Product Type: Drug
Control Number: 223819
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-01-18
Decision / Authorization Date: 2019-12-13