Review decisions

Showing 10 results of 2190 total
Summary Safety Review - Nexavar (sorafenib) - Assessing the Potential Risk of Tumour Lysis Syndrome
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1715006032208
DIN(s): 02284227
Issued / Original Publication Date: 2024-05-16
Updated Date: 2024-05-16
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 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 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
Regulatory Decision Summary for Viagra
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714658462376
Product Type: Drug
Control Number: 274068
DIN(s): 02239766, 02239767, 02239768, 02544172
Manufacturer: BGP Pharma ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-04-04
Decision / Authorization Date: 2023-12-28
Regulatory Decision Summary for Verzenio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714680266149
Product Type: Drug
Control Number: 270898
DIN(s): 02487098, 02487101, 02487128, 02487136
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-21
Decision / Authorization Date: 2023-12-06
Regulatory Decision Summary for Bimzelx
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1712149040145
Product Type: Drug
Control Number: 273663
DIN(s): 02525267, 02525275
Manufacturer: UBC Canada Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-27
Decision / Authorization Date: 2024-03-11

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