Review decisions

Showing 10 results of 2304 total
Regulatory Decision Summary for Illuccix
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1734622818009
Product Type: Drug
Control Number: 279567
DIN(s): 02531836
Manufacturer: Telix Pharmaceuticals (US) Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-06
Decision / Authorization Date: 2024-09-20
Regulatory Decision Summary for Jamteki / Jamteki I.V.
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1734360561368
Product Type: Drug
Control Number: 285419
DIN(s): 02543036, 02543044, 02553120
Manufacturer: JAMP Pharma Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-03-28
Decision / Authorization Date: 2024-11-13
Summary Safety Review - Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel) - Chimeric Antigen Receptor T-cell (CAR-T) Therapies - Assessing the Potential Risk of Secondary T-cell Malignancy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1733492722458
DIN(s): 02480514, 02485648, 02516667, 02527138, 02532719, 02535270
Issued / Original Publication Date: 2024-12-11
Updated Date: 2024-12-11
Summary Safety Review - HMG-CoA Reductase Inhibitors (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin) - Statins - Assessing the Potential Risk of Myasthenia Gravis, Including Ocular Myasthenia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1732733593751
DIN(s): 00884332, 00884340, 00884359, 02220172, 02220180, 02230711, 02230713, 02230714, 02243097, 02243506, 02243507, 02243508, 02243824, 02243825, 02243826, 02246013, 02246014, 02247008, 02247009, 02247010, 02247011, 02247012, 02247013, 02247014, 02247015, 02247162, 02247163, 02247164, 02247220, 02247221, 02247222, 02247223, 02247224, 02247231, 02247232, 02247655, 02247656, 02247657, 02248572, 02248573, 02249723, 02249731, 02249758, 02250144, 02250152, 02250160, 02250179, 02250187, 02253747, 02253755, 02253763, 02253771, 02253798, 02265540, 02269252, 02269260, 02269279, 02269287, 02269295, 02273233, 02273241, 02273268, 02273276, 02273284, 02273292, 02273306, 02273314, 02281619, 02281627, 02281635, 02281643, 02281651, 02284421, 02284448, 02284456, 02284723, 02284731, 02284758, 02284766, 02284774, 02295261, 02295288, 02295296, 02295318, 02299224, 02299232, 02310899, 02310902, 02310910, 02310929, 02313707, 02313715, 02313723, 02313758, 02317451, 02317478, 02317486, 02324946, 02324954, 02324962, 02324970, 02329131, 02329158, 02329166, 02329174, 02329182, 02330954, 02330962, 02330970, 02331969, 02331985, 02331993, 02332000, 02332019, 02332191, 02332205, 02332213, 02333724, 02333732, 02333740, 02333759, 02337975, 02337983, 02337991, 02338009, 02338726, 02338734, 02338742, 02338750, 02346486, 02346494, 02346508, 02346516, 02348705, 02348713, 02348721, 02348748, 02354608, 02354616, 02354624, 02354632, 02356546, 02356554, 02356562, 02362759, 02362767, 02362775, 02362783, 02362791, 02362805, 02362813, 02362821, 02372932, 02372940, 02372959, 02372967, 02372975, 02374625, 02374633, 02374641, 02374668, 02374676, 02375036, 02375044, 02375052, 02375060, 02375079, 02375591, 02375605, 02375613, 02375621, 02375648, 02376040, 02376059, 02376067, 02376075, 02376083, 02378523, 02378531, 02378558, 02378566, 02380013, 02380056, 02380064, 02380102, 02381176, 02381184, 02381192, 02381206, 02382644, 02382652, 02382660, 02382679, 02386291, 02386305, 02386313, 02386321, 02386348, 02386704, 02386712, 02386720, 02386739, 02389355, 02389401, 02389428, 02389436, 02389541, 02389568, 02389576, 02389584, 02389703, 02389738, 02389746, 02391058, 02391066, 02391074, 02391082, 02392933, 02392941, 02392968, 02392976, 02396424, 02396432, 02396440, 02396459, 02397781, 02397803, 02397811, 02397838, 02399164, 02399172, 02399180, 02399199, 02399482, 02399490, 02399504, 02399512, 02404222, 02404230, 02404249, 02404257, 02405148, 02405156, 02405164, 02405172, 02405180, 02405628, 02405636, 02405644, 02405652, 02407256, 02407264, 02407272, 02407280, 02410931, 02410958, 02410966, 02410974, 02411253, 02411288, 02411296, 02411318, 02411326, 02411334, 02411342, 02411350, 02411369, 02411377, 02411385, 02411628, 02411636, 02411644, 02411652, 02413051, 02413078, 02413086, 02413108, 02417936, 02417944, 02417952, 02417960, 02422751, 02422778, 02422786, 02422794, 02427257, 02427265, 02427702, 02427710, 02427729, 02427737, 02430967, 02430975, 02430983, 02432048, 02432056, 02432064, 02435292, 02435306, 02435314, 02435322, 02438917, 02438925, 02438933, 02438941, 02440644, 02440652, 02440660, 02442574, 02442582, 02442590, 02442604, 02444968, 02444976, 02444984, 02444992, 02446251, 02446278, 02446286, 02454017, 02454025, 02454033, 02454041, 02457741, 02457768, 02457776, 02457784, 02458977, 02458985, 02458993, 02468700, 02468719, 02468727, 02469979, 02469987, 02469995, 02470004, 02470012, 02471167, 02471175, 02471183, 02471191, 02475022, 02475030, 02475049, 02475057, 02476142, 02476150, 02476169, 02476274, 02476282, 02476290, 02476517, 02476525, 02476533, 02476541, 02477149, 02477157, 02477165, 02477173, 02477483, 02477491, 02477505, 02477513, 02479508, 02479516, 02479524, 02479532, 02480050, 02480069, 02480077, 02480085, 02480093, 02481189, 02481197, 02481200, 02481219, 02496054, 02496062, 02496070, 02496089, 02496534, 02496542, 02496550, 02496569, 02496607, 02496615, 02496623, 02496631, 02498332, 02498340, 02498359, 02498367, 02500132, 02500140, 02500159, 02500167, 02504197, 02504200, 02504219, 02504235, 02505576, 02505584, 02505592, 02505606, 02506076, 02506084, 02506092, 02506106, 02507234, 02507242, 02507250, 02507269, 02521555, 02521563, 02521571, 02521598, 02529947, 02529955, 02529963, 02529971, 02535653, 02535661, 02535688, 02536595, 02536609, 02536625, 02536633, 02545462, 02545470, 02545489, 02545497
Issued / Original Publication Date: 2024-12-04
Updated Date: 2024-12-04
Summary Safety Review - Ilaris (canakinumab) – Assessing the Potential Risk of Drug Reaction with Eosinophilia and Systemic Symptoms
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1732291653402
DIN(s): 02344939, 02460351
Issued / Original Publication Date: 2024-11-27
Updated Date: 2024-11-27
Summary Safety Review - Cyclosporine - Assessing the Potential Risk of Hearing Impairment
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1732114128847
DIN(s): 00593257, 02150662, 02150670, 02150689, 02150697, 02237671, 02242821, 02247073, 02247074, 02355655, 02462486, 02476835, 02484137, 02495805, 02495813, 02495821, 02512629
Issued / Original Publication Date: 2024-11-22
Updated Date: 2024-11-22
Summary Safety Review - Dasatinib - Assessing the Potential Risk of Delayed Growth In Children
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1731422768944
DIN(s): 02293129, 02293137, 02293145, 02320193, 02360810, 02360829, 02470705, 02470713, 02470721, 02478307, 02478315, 02478323, 02478331, 02478358, 02481499, 02481502, 02499282, 02499304, 02499312, 02499320, 02499339, 02499347, 02514737, 02514745, 02514753, 02514761, 02514788, 02514796
Issued / Original Publication Date: 2024-11-15
Updated Date: 2024-11-15
Regulatory Decision Summary for Tyenne
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1729607296633
Product Type: Drug
Control Number: 280011
DIN(s): 02552450, 02552469, 02552477, 02552485, 02552493
Manufacturer: Fresenius Kabi Canada Ltd
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-17
Decision / Authorization Date: 2024-10-11
Regulatory Decision Summary for Wainua
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1730840018921
Product Type: Drug
Control Number: 274598
DIN(s): 02548909
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-21
Decision / Authorization Date: 2024-06-19
Regulatory Decision Summary for Zilbrysq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732026718824
Product Type: Drug
Control Number: 276757
DIN(s): 02549220, 02549239, 02549247
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-06-30
Decision / Authorization Date: 2024-07-11

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