Review decisions
Showing 770 results of 1550 total
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/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/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/RDS01026
Product Type: Drug
Control Number: 240668
DIN(s): 02510197, 02510200
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2020-06-15
Decision / Authorization Date: 2021-01-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00803
Product Type: Drug
Control Number: 239943
DIN(s): 02510219, 02510227
Manufacturer: Kye Pharmaceuticals Inc., Canada
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-05-27
Decision / Authorization Date: 2020-12-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00775
Product Type: Drug
Control Number: 231585
DIN(s): 02510324
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-01-16
Decision / Authorization Date: 2020-12-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00744
Product Type: Drug
Control Number: 221579
DIN(s): 02508613
Manufacturer: Verity Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-11-01
Decision / Authorization Date: 2020-12-24