Review decisions
Showing 510 results of 1553 total
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01065
Product Type: Drug
Control Number: 257230
DIN(s): 02525569
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-10-04
Decision / Authorization Date: 2022-09-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01014
Product Type: Drug
Control Number: 262952
Manufacturer: ModernaTX, Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-04-01
Decision / Authorization Date: 2022-09-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01000
Product Type: Drug
Control Number: 254848
DIN(s): 02530589
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-14
Decision / Authorization Date: 2022-09-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01050
Product Type: Drug
Control Number: 240337
Manufacturer: Kye Pharmaceuticals Inc., Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-05
Decision / Authorization Date: 2022-09-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00993
Product Type: Drug
Control Number: 265483
DIN(s): 02530325
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech
Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-06-23
Decision / Authorization Date: 2022-09-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01072
Product Type: Drug
Control Number: 256159
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-08-26
Decision / Authorization Date: 2022-09-09