Review decisions
Showing 860 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00878
Product Type: Drug
Control Number: 257162
DIN(s): 02509210
Manufacturer: BioNTech Manufacturing GmbH. Importer: Pfizer Canada ULC.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2021-10-01
Decision / Authorization Date: 2021-11-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00886
Product Type: Drug
Control Number: 247542
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-15
Decision / Authorization Date: 2021-11-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00888
Product Type: Drug
Control Number: 237499
DIN(s): 02522160, 02522179
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-06-07
Decision / Authorization Date: 2021-11-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00589
Product Type: Drug
Control Number: 258295
DIN(s): 02526271
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-11-03
Issued / Original Publication Date: 2022-06-15
Decision / Authorization Date: 2022-04-14
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00885
Product Type: Drug
Control Number: 251438
DIN(s): 02521903, 02521911
Manufacturer: Seagen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-06
Decision / Authorization Date: 2021-10-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00903
Product Type: Drug
Control Number: 237738
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-03-30
Decision / Authorization Date: 2021-10-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01004
Product Type: Drug
Control Number: 236566
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-02-26
Decision / Authorization Date: 2021-10-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00877
Product Type: Drug
Control Number: 247339
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-11
Decision / Authorization Date: 2021-10-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00884
Product Type: Drug
Control Number: 246918
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-01
Decision / Authorization Date: 2021-10-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00894
Product Type: Drug
Control Number: 246729
DIN(s): 02521679, 02521687
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-24
Decision / Authorization Date: 2021-10-26