Review decisions

Showing 70 results of 2299 total
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
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

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