Review decisions

Showing 50 results of 2270 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
Summary Safety Review - Iodinated Contrast Medium - Assessing the Potential Risk of Hypothyroidism in Children Under 3 Years of Age
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
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
Summary Safety Review - Neulasta (pegfilgrastim) - Assessing the Potential Risks of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1712840271387
DIN(s): 02249790, 02474565, 02484153, 02497395, 02506238, 02529343
Issued / Original Publication Date: 2024-04-19
Updated Date: 2024-04-19
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
Regulatory Decision Summary for Xtandi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714051494769
Product Type: Drug
Control Number: 277282
DIN(s): 02407329
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-07-17
Decision / Authorization Date: 2024-01-05

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