Review decisions

Showing 2360 results of 2631 total
Summary Basis of Decision for Viibryd
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00246
Product Type: Drug
Control Number: 176820
DIN(s): 02443732, 02443740, 02443759
Manufacturer: Forest Laboratories Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-07-29
Issued / Original Publication Date: 2015-09-30
Decision / Authorization Date: 2015-07-16
Updated Date: 2025-08-05
Summary Safety Review - Topical Antiseptic Products - Risk of Infection
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00057
Issued / Original Publication Date: 2014-07-25
Summary Safety Review - Testosterone Replacement Products - Cardiovascular Risk
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00058
Issued / Original Publication Date: 2014-07-15
Summary Basis of Decision for Ofev
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00236
Product Type: Drug
Control Number: 176043
DIN(s): 02443066, 02443074
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-07-09
Issued / Original Publication Date: 2015-08-21
Decision / Authorization Date: 2015-06-25
Updated Date: 2024-08-08
Summary Basis of Decision for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00227
Product Type: Drug
Control Number: 175884
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2014-06-26
Issued / Original Publication Date: 2015-07-23
Decision / Authorization Date: 2015-05-19
Updated Date: 2022-10-28
Summary Basis of Decision for Zykadia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00206
Product Type: Drug
Control Number: 175702
DIN(s): 02436779
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2014-06-16
Issued / Original Publication Date: 2015-06-17
Decision / Authorization Date: 2015-03-27
Updated Date: 2026-01-26
Summary Basis of Decision for Pheburane
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00261
Product Type: Drug
Control Number: 175573
DIN(s): 02436663
Manufacturer: Medunik Canada
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2014-06-13
Issued / Original Publication Date: 2015-05-01
Decision / Authorization Date: 2015-01-26
Updated Date: 2025-08-27
Summary Safety Review - Serotonin blocking drugs (serotonin antagonists) ALOXI ® (palonosetron), ANZEMET ® (dolasetron), KYTRIL ® (granisetron) and generics, and ZOFRAN ® (ondansetron) and generics - Serotonin Syndrome
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00059
Issued / Original Publication Date: 2014-05-14
Summary Basis of Decision for Giotrif
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00248
Product Type: Drug
Control Number: 158730
DIN(s): 02415666, 02415674, 02415682
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2014-05-12
Updated Date: 2021-11-02
Summary Basis of Decision for Sylvant
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00193
Product Type: Drug
Control Number: 174291
DIN(s): 02435128, 02435136
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2014-04-28
Issued / Original Publication Date: 2015-05-15
Decision / Authorization Date: 2014-12-03
Updated Date: 2026-02-16

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