Review decisions

Showing 50 results of 1317 total
Regulatory Decision Summary for Camzyos
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
Regulatory Decision Summary for Okedi
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
Regulatory Decision Summary for Qulipta
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
Regulatory Decision Summary for Combogesic IV
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
Regulatory Decision Summary for Teva-Sapropterin
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1718027763592
Product Type: Drug
Control Number: 265907
Manufacturer: Teva Canada Limited
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2022-09-01
Decision / Authorization Date: 2024-05-03
Regulatory Decision Summary for Zejula
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1716577628323
Product Type: Drug
Control Number: 262892
DIN(s): 02489783, 02530031
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-30
Decision / Authorization Date: 2024-01-12
Regulatory Decision Summary for Niopeg
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714499567288
Product Type: Drug
Control Number: 262438
DIN(s): 02546973
Manufacturer: Nora Pharma
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-17
Decision / Authorization Date: 2024-04-17
Regulatory Decision Summary for Skyrizi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714053364853
Product Type: Drug
Control Number: 274993
DIN(s): 02546922
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-03
Decision / Authorization Date: 2024-04-05
Regulatory Decision Summary for Yescarta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1713813660399
Product Type: Drug
Control Number: 259651
DIN(s): 02485648
Manufacturer: Gilead Sciences Canada Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-15
Decision / Authorization Date: 2022-12-06
Regulatory Decision Summary for Keytruda (pembrolizumab)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1713542168989
Product Type: Drug
Control Number: 275053
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-05
Decision / Authorization Date: 2024-04-12

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