Review decisions

Showing 30 results of 2294 total
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
Summary Safety Review - Breast Implants - Assessing the Potential Risk of Breast Implant Illness Representative Symptoms and Diseases
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1722261038121
Issued / Original Publication Date: 2024-08-09
Updated Date: 2024-08-09
Regulatory Decision Summary for Steqeyma/Steqeyma IV
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722628438095
Product Type: Drug
Control Number: 274939
DIN(s): 02550245, 02550253, 02550261
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-30
Decision / Authorization Date: 2024-07-30
Regulatory Decision Summary for Argatroban
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1729525313633
Product Type: Drug
Control Number: 282415
DIN(s): 02243835, 02548968
Manufacturer: Sandoz Canada Incorporated
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-12-22
Decision / Authorization Date: 2024-06-28

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