Review decisions

Showing 610 results of 820 total
Regulatory Decision Summary for SMOFKABIVEN ELECTROLYTE FREE (5.1% Amino Acids, 17.7% Dextrose, 3.8% Lipids)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00103
Product Type: Drug
Control Number: 168934
DIN(s): 02440687
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-05-14
Decision / Authorization Date: 2015-04-30
Regulatory Decision Summary for Duaklir Genuair
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00015
Product Type: Drug
Control Number: 172711
DIN(s): 02439530
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-03-03
Decision / Authorization Date: 2015-04-02
Regulatory Decision Summary for ICLUSIG
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00083
Product Type: Drug
Control Number: 165121
DIN(s): 02437333, 02437341
Manufacturer: ARIAD Pharmaceuticals, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2013-05-23
Decision / Authorization Date: 2015-04-02
Summary Basis of Decision for Holkira Pak
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00250
Product Type: Drug
Control Number: 174739
DIN(s): 02436027
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-03-19
Updated Date: 2020-10-08
Summary Basis of Decision for Harvoni
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00249
Product Type: Drug
Control Number: 173180
DIN(s): 02432226
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-01-12
Updated Date: 2022-10-28
Summary Basis of Decision for Trintellix
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00197
Product Type: Drug
Control Number: 159019
DIN(s): 02432919, 02432927, 02432935, 02432943
Manufacturer: Lundbeck Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2014-12-11
Updated Date: 2021-11-30
Summary Basis of Decision for Basaglar
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00281
Product Type: Drug
Control Number: 177405
DIN(s): 02444844, 02444852, 02461528
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-08-29
Issued / Original Publication Date: 2015-10-21
Decision / Authorization Date: 2015-09-01
Updated Date: 2024-07-26
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 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 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

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