Review decisions
Showing 620 results of 1550 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00912
Product Type: Drug
Control Number: 254251
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-28
Decision / Authorization Date: 2022-01-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01068
Product Type: Drug
Control Number: 248754
DIN(s): 02523930
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-01-25
Decision / Authorization Date: 2022-01-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00906
Product Type: Drug
Control Number: 247265
DIN(s): 02523760, 02523779
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-12
Decision / Authorization Date: 2021-12-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00901
Product Type: Drug
Control Number: 248134
DIN(s): 02523191
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-08
Decision / Authorization Date: 2021-12-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692123802448
Product Type: Drug
Control Number: 246457
DIN(s): 02443937, 02443945
Manufacturer: Boehringer Ingelheim (Canada) Ltd Ltee
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-11-16
Decision / Authorization Date: 2021-10-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00910
Product Type: Drug
Control Number: 247842
Manufacturer: BGP Pharma ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-23
Decision / Authorization Date: 2021-12-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00897
Product Type: Drug
Control Number: 246187
DIN(s): 02522845
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-09
Decision / Authorization Date: 2021-11-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00898
Product Type: Drug
Control Number: 246936
Manufacturer: BGP Pharma ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-11-30
Decision / Authorization Date: 2021-11-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00900
Product Type: Drug
Control Number: 247369
DIN(s): 02522829, 02522837
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-12
Decision / Authorization Date: 2021-11-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00955
Product Type: Drug
Control Number: 247561
DIN(s): 02522772
Manufacturer: SIGA Technologies, Inc.
Submission Type: Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2020-12-22
Decision / Authorization Date: 2021-11-29