Review decisions

Showing 20 results of 2379 total
Regulatory Decision Summary for Eylea HD (aflibercept)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1741809569789
Product Type: Drug
Control Number: 285427
DIN(s): 02545004, 02554798
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-03-28
Decision / Authorization Date: 2025-03-03
Regulatory Decision Summary for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1742997691925
Product Type: Drug
Control Number: 274453
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-04-17
Decision / Authorization Date: 2025-02-06
Summary Safety Review - Oral Anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban and warfarin) - Assessing the Potential Risk of Splenic Rupture
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1740076495316
DIN(s): 02242680, 02242681, 02242682, 02242683, 02242684, 02242685, 02242686, 02242687, 02242697, 02242924, 02242925, 02242926, 02242927, 02242928, 02242929, 02245618, 02312433, 02312441, 02316986, 02358808, 02377233, 02378604, 02378612, 02397714, 02458640, 02458659, 02458667, 02463458, 02463466, 02468891, 02468905, 02468913, 02470497, 02470500, 02470519, 02472414, 02472422, 02472430, 02482223, 02482231, 02482258, 02483807, 02483815, 02483823, 02484994, 02485001, 02486806, 02486814, 02487381, 02487403, 02487519, 02487527, 02487713, 02487721, 02489228, 02489236, 02492369, 02492377, 02492814, 02492822, 02495430, 02495449, 02507196, 02507218, 02507226, 02508117, 02508125, 02508133, 02508141, 02510162, 02510170, 02510464, 02510472, 02512041, 02512068, 02512076, 02515237, 02515245, 02515253, 02516292, 02516306, 02516314, 02518651, 02518678, 02518686, 02518694, 02524503, 02525518, 02525526, 02526050, 02526069, 02526786, 02527537, 02527979, 02527987, 02527995, 02528002, 02528010, 02528924, 02528932, 02529009, 02529017, 02529912, 02529920, 02530708, 02530716, 02530724, 02530732, 02537877, 02540835, 02540843, 02540851, 02540878, 02540967, 02540975, 02540983, 02540991, 02541467, 02541475, 02541483, 02541491, 02541734, 02546884, 02546892, 02547295, 02547589, 02547597, 02547600, 02547619, 02547899, 02547902, 02547910, 02547929, 02548879, 02548887, 02549328, 02549336, 02549344, 02549352
Issued / Original Publication Date: 2025-02-28
Updated Date: 2025-02-28
Summary Safety Review - Isotretinoin - Assessing the Potential Risk of Sacroiliitis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1739474283557
DIN(s): 00582344, 00582352, 02257955, 02257963, 02309173, 02396971, 02396998, 02397005, 02397013, 02539047, 02539055, 02539063, 02539071
Issued / Original Publication Date: 2025-02-19
Updated Date: 2025-02-19
Regulatory Decision Summary for Kloxxado
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1741871370149
Product Type: Drug
Control Number: 281754
DIN(s): 02555441
Manufacturer: Hikma Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-04
Decision / Authorization Date: 2025-02-12
Regulatory Decision Summary for Skyrizi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1739369525149
Product Type: Drug
Control Number: 280386
DIN(s): 02552507
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-26
Decision / Authorization Date: 2024-10-10
Regulatory Decision Summary for Proquad
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1738942976198
Product Type: Drug
Control Number: 283956
DIN(s): 02399229
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-02-15
Decision / Authorization Date: 2025-01-20
Summary Safety Review - Glucagon-like Peptide 1 Receptor Agonists (GLP-1 RAs) (dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide) - Assessing the Potential Risks of Suicide, Self-harm and Suicidal/Self-harm Ideation
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1737728420090
DIN(s): 02437899, 02448599, 02448602, 02471469, 02471477, 02474875, 02478293, 02497581, 02497603, 02497611, 02528509, 02528517, 02528525, 02528533, 02528541, 02540258
Issued / Original Publication Date: 2025-02-06
Updated Date: 2025-02-06
Regulatory Decision Summary for Aripiprazole Oral Solution
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1745332115316
Product Type: Drug
Control Number: 286599
DIN(s): 02554550
Manufacturer: Orimed Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-05-31
Decision / Authorization Date: 2025-01-15
Regulatory Decision Summary for Casgevy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1738688279298
Product Type: Drug
Control Number: 284351
DIN(s): 02552043
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-02-27
Decision / Authorization Date: 2024-09-23

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