Review decisions

Showing 330 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1766087719555
Product Type: Drug
Control Number: 286134
DIN(s): 02561883, 02561891
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-05-28
Issued / Original Publication Date: 2025-12-22
Decision / Authorization Date: 2025-10-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1717694387694
Product Type: Drug
Control Number: 273215
DIN(s): 02512963
Manufacturer: Beigene Switzerland GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-10
Decision / Authorization Date: 2024-02-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1718716557847
Product Type: Drug
Control Number: 273103
DIN(s): 02243005
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-07
Decision / Authorization Date: 2024-02-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1718733982360
Product Type: Drug
Control Number: 274859
DIN(s): 02544733, 02544741
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-28
Decision / Authorization Date: 2024-01-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1723558762833
Product Type: Drug
Control Number: 272517
DIN(s): 02532549, 02532557, 02532565, 02532573
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-16
Decision / Authorization Date: 2024-02-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1715006032208
DIN(s): 02284227
Issued / Original Publication Date: 2024-05-16
Updated Date: 2024-05-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722527517248
Product Type: Drug
Control Number: 264840
DIN(s): 02544601, 02544628
Manufacturer: Laboratorios Farmaceuticos Rovi, S.A.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-06-03
Decision / Authorization Date: 2024-03-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722529358548
Product Type: Drug
Control Number: 273484
DIN(s): 02533979, 02533987, 02533995
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-20
Decision / Authorization Date: 2024-05-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1730395674104
Product Type: Drug
Control Number: 260262
DIN(s): 02544806
Manufacturer: Biosyent Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-01-11
Decision / Authorization Date: 2024-02-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1714657204971
DIN(s): 00386685, 00397466, 01900854, 02035626, 02078600, 02078619, 02145766, 02145774, 02172739, 02172747, 02172755, 02228564, 02229013, 02229021, 02229048, 02242121, 02242122, 02387441
Issued / Original Publication Date: 2024-05-10
Updated Date: 2024-05-10