Review decisions
Showing 740 results of 2304 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00754
Product Type: Drug
Control Number: 235672
DIN(s): 02510936
Manufacturer: Sanofi Pasteur Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-01-31
Decision / Authorization Date: 2021-01-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00761
Product Type: Drug
Control Number: 235685
DIN(s): 02511045, 02511053, 02511061, 02511088, 02511096
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-01-31
Decision / Authorization Date: 2021-01-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00562
Product Type: Drug
Control Number: 248435
DIN(s): 02520095
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-01-14
Issued / Original Publication Date: 2021-12-07
Decision / Authorization Date: 2021-09-10
Updated Date: 2024-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692978760470
Product Type: Drug
Control Number: 240372
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-13
Decision / Authorization Date: 2023-05-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00745
Product Type: Drug
Control Number: 233288
DIN(s): 02510839
Manufacturer: Lundbeck Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-02-03
Decision / Authorization Date: 2021-01-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724855581143
Product Type: Drug
Control Number: 256264
Manufacturer: Hoffman-La Roche Limited
Submission Type: New Drug Submission with flexibilities filed for COVID-19 Drug products (NDS-CV)
Date Filed / Submission Date: 2021-01-09
Decision / Authorization Date: 2024-06-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00771
Product Type: Drug
Control Number: 235656
DIN(s): 02510243
Manufacturer: Bausch Health, Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-01-30
Decision / Authorization Date: 2021-01-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00255
Issued / Original Publication Date: 2021-01-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00752
Product Type: Drug
Control Number: 235556
DIN(s): 02510561, 02510588
Manufacturer: Seqirus UK Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-01-28
Decision / Authorization Date: 2021-01-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00585
Product Type: Drug
Control Number: 244990
DIN(s): 02523949, 02523957, 02523965
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-07
Issued / Original Publication Date: 2022-04-14
Decision / Authorization Date: 2022-01-05
Updated Date: 2024-07-29