Review decisions

Showing 2040 results of 2304 total
Summary Basis of Decision for Obizur
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00240
Product Type: Drug
Control Number: 177290
DIN(s): 02447401
Manufacturer: Baxalta Canada Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-08-15
Issued / Original Publication Date: 2015-12-03
Decision / Authorization Date: 2015-10-14
Updated Date: 2024-02-20
Summary Safety Review - NEUPOGEN (filgrastim) and NEULASTA (pegfilgrastim) - Capillary Leak Syndrome
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00056
Issued / Original Publication Date: 2014-07-29
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: 2024-03-04
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 Basis of Decision for Saflutan
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00243
Product Type: Drug
Control Number: 165596
DIN(s): 02425149
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2014-07-16
Updated Date: 2018-06-05
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 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: 2024-12-20
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

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