Review decisions

Showing 1950 results of 2199 total
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 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: 2022-11-24
Summary Basis of Decision for Ravicti
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00296
Product Type: Drug
Control Number: 174219
DIN(s): 02453304
Manufacturer: Horizon Pharma Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-04-25
Issued / Original Publication Date: 2016-07-07
Decision / Authorization Date: 2016-03-18
Updated Date: 2023-08-11
Summary Basis of Decision for Imbruvica
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00252
Product Type: Drug
Control Number: 174029
DIN(s): 02434407, 02486733, 02486741, 02486768, 02486776
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2014-04-17
Issued / Original Publication Date: 2015-03-18
Decision / Authorization Date: 2014-11-17
Updated Date: 2022-11-28
Summary Safety Review - DIANE 35 (Cyproterone Acetate and Ethinyl Estradiol) - Venous Thromboembolism (blood clot)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00060
Issued / Original Publication Date: 2014-04-08
Updated Date: 2014-11-17
Summary Basis of Decision for Juxtapid
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00224
Product Type: Drug
Control Number: 160385
DIN(s): 02420341, 02420376, 02420384
Manufacturer: Aegerion Pharmaceuticals Canada Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2014-04-07
Updated Date: 2017-11-08
Summary Basis of Decision for Xofigo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00201
Product Type: Drug
Control Number: 161312
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2014-03-04
Updated Date: 2020-10-06

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