Review decisions
Showing 1280 results of 2627 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/SBD00458
Product Type: Drug
Control Number: 220584
DIN(s): 02492032, 02492040
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-01-21
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/SBD00514
Product Type: Drug
Control Number: 237194
DIN(s): 02506343
Manufacturer: Alnylam Netherlands B.v.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-01-19
Issued / Original Publication Date: 2021-01-21
Decision / Authorization Date: 2020-10-09
Updated Date: 2025-07-29
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/SBD00524
Product Type: Drug
Control Number: 235023
DIN(s): 02509733
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-01-09
Issued / Original Publication Date: 2021-03-25
Decision / Authorization Date: 2020-12-17
Updated Date: 2023-10-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00496
Product Type: Drug
Control Number: 234610
DIN(s): 02501600
Manufacturer: Otsuka Pharmaceutical Co., Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-12-31
Issued / Original Publication Date: 2020-09-21
Decision / Authorization Date: 2020-07-07
Updated Date: 2024-09-23
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