Review decisions

Showing 30 results of 2299 total
Regulatory Decision Summary for Dupixent
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1727874290637
Product Type: Drug
Control Number: 283782
DIN(s): 02470365, 02492504, 02510049, 02524252
Manufacturer: Sanofi-Aventis Canada Inc
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-02-09
Decision / Authorization Date: 2024-09-06
Summary Safety Review - Olanzapine - Assessing the Potential Risks of Syndrome of Inappropriate Secretion of Antidiuretic Hormone and Hyponatremia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1725462803755
DIN(s): 02229250, 02229269, 02229277, 02229285, 02238850, 02238851, 02243086, 02243087, 02243088, 02243089, 02247099, 02276712, 02276720, 02276739, 02276747, 02276755, 02281791, 02281805, 02281813, 02281821, 02281848, 02303116, 02303159, 02303167, 02303175, 02303183, 02303191, 02303205, 02303213, 02310341, 02310368, 02310376, 02310384, 02310392, 02311968, 02311976, 02311984, 02311992, 02312018, 02327775, 02327783, 02327791, 02327805, 02333015, 02337126, 02337134, 02337142, 02337150, 02337169, 02338645, 02338653, 02338661, 02343665, 02343673, 02343681, 02343703, 02352974, 02352982, 02352990, 02359707, 02360616, 02360624, 02360632, 02360640, 02372819, 02372827, 02372835, 02372843, 02372851, 02385864, 02385872, 02385880, 02385899, 02385902, 02385910, 02406624, 02406632, 02406640, 02406659, 02410141, 02410168, 02410176, 02410184, 02410192, 02417243, 02417251, 02417278, 02417286, 02417294, 02417308, 02421704, 02425114, 02436965, 02436973, 02436981, 02448726, 02448734, 02448742, 02448750, 02487608, 02487616, 02487632, 02536188, 02536196, 02536218, 02536226, 02545586, 02545594, 02545608, 02545616, 02545624, 02545632
Issued / Original Publication Date: 2024-09-06
Updated Date: 2024-09-06
Regulatory Decision Summary for Adheroza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1725633192834
Product Type: Drug
Control Number: 275910
DIN(s): 02550970, 02550989
Manufacturer: Accord Healthcare Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-01
Decision / Authorization Date: 2024-08-20
Regulatory Decision Summary for Accrufer
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1727446158111
Product Type: Drug
Control Number: 260666
DIN(s): 02550679
Manufacturer: Kye Pharmaceuticals
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-03-18
Decision / Authorization Date: 2024-08-21
Regulatory Decision Summary for Keytruda (pembrolizumab)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724779172737
Product Type: Drug
Control Number: 282981
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-01-19
Decision / Authorization Date: 2024-08-20
Regulatory Decision Summary for Padcev (enfortumab vedotin)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724850954021
Product Type: Drug
Control Number: 283003
Manufacturer: Seagen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-01-22
Decision / Authorization Date: 2024-08-20
Summary Safety Review - Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors (canagliflozin, dapagliflozin, empagliflozin) - Assessing the Potential Risks of Prolonged or Incident Diabetic Ketoacidosis Despite Stopping Treatment in Adult Patients with Type 2 Diabetes
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1724175682293
DIN(s): 02425483, 02425491, 02435462, 02435470, 02443937, 02443945, 02449935, 02449943, 02455404, 02455420, 02455439, 02455455, 02456575, 02456583, 02456591, 02456605, 02456613, 02456621, 02518732, 02518740, 02519852, 02519860, 02520591, 02520605, 02523590, 02523604, 02527189, 02527197, 02528975, 02528983, 02531364, 02531372, 02531402, 02531410, 02531550, 02531569, 02533049, 02533057, 02533073, 02533081, 02535297, 02535300, 02535866, 02535874, 02536153, 02536161, 02537656, 02537664, 02538334, 02538342, 02543184, 02543192
Issued / Original Publication Date: 2024-08-21
Updated Date: 2024-08-21
Regulatory Decision Summary for Armlupeg
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724332454521
Product Type: Drug
Control Number: 262990
Manufacturer: Lupin Pharma Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-31
Decision / Authorization Date: 2024-08-16
Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724776566772
Product Type: Drug
Control Number: 277532
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-07-26
Decision / Authorization Date: 2024-08-07
Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724778020977
Product Type: Drug
Control Number: 278712
DIN(s): 02550520, 02550539, 02550547
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-08-30
Decision / Authorization Date: 2024-08-07

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