Review decisions

Showing 250 results of 2270 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1715623184650
Product Type: Drug
Control Number: 272785
DIN(s): 02544040
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-02-27
Issued / Original Publication Date: 2024-05-10
Decision / Authorization Date: 2023-12-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1707490019947
Product Type: Drug
Control Number: 272688
DIN(s): 02541769
Manufacturer: Ultragenyx Pharmaceutical, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-02-24
Issued / Original Publication Date: 2023-02-08
Decision / Authorization Date: 2024-02-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1695394418545
Product Type: Drug
Control Number: 256191
DIN(s): 02532530, 02532581
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-27
Decision / Authorization Date: 2022-11-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697043337700
Product Type: Drug
Control Number: 262122
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-03-04
Decision / Authorization Date: 2023-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01076
Product Type: Drug
Control Number: 269428
Manufacturer: ModernaTX, Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-11-04
Decision / Authorization Date: 2023-02-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00625
Product Type: Drug
Control Number: 259676
DIN(s): 02530740
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2023-02-17
Updated Date: 2023-02-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01074
Product Type: Drug
Control Number: 267263
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-08-24
Decision / Authorization Date: 2023-02-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1695925210899
Product Type: Drug
Control Number: 255032
DIN(s): 02534622
Manufacturer: Chiesi Farmaceutici S.p.a.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-07-22
Decision / Authorization Date: 2023-01-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00292
Issued / Original Publication Date: 2023-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708023990983
Product Type: Drug
Control Number: 271756
Manufacturer: Galderma SA
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-02-09
Decision / Authorization Date: 2024-01-16