Review decisions
Showing 500 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01010
Product Type: Drug
Control Number: 258009
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-10-26
Decision / Authorization Date: 2022-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01018
Product Type: Drug
Control Number: 258125
Manufacturer: Sandoz Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-10-28
Decision / Authorization Date: 2022-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01093
Product Type: Drug
Control Number: 257242
DIN(s): 02531593, 02531607, 02531615
Manufacturer: Auro Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-11-29
Decision / Authorization Date: 2022-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01006
Product Type: Drug
Control Number: 267502
DIN(s): 02531461
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-09-02
Decision / Authorization Date: 2022-10-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01063
Product Type: Drug
Control Number: 257734
Manufacturer: Apotex Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-09-10
Decision / Authorization Date: 2022-10-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01021
Product Type: Drug
Control Number: 262749
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-24
Decision / Authorization Date: 2022-09-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01007
Product Type: Drug
Control Number: 256106
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-08-26
Decision / Authorization Date: 2022-09-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01064
Product Type: Drug
Control Number: 262782
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-02-25
Decision / Authorization Date: 2022-09-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01001
Product Type: Drug
Control Number: 257192
Manufacturer: Merz Pharmaceuticals GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-09-29
Decision / Authorization Date: 2022-09-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01097
Product Type: Drug
Control Number: 238027
DIN(s): 02531186
Manufacturer: Glenmark Specialty SA
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-04-15
Decision / Authorization Date: 2022-09-21