Review decisions

Showing 2220 results of 2627 total
Summary Basis of Decision for Renflexis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00379
Product Type: Drug
Control Number: 188114
DIN(s): 02470373
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-09-30
Issued / Original Publication Date: 2018-02-02
Decision / Authorization Date: 2017-12-01
Updated Date: 2024-02-16
Summary Safety Review - OCTAGAM 5% and OCTAGAM 10% (Immune Globulin Intravenous [Human]) - Assessing Lack of Effectiveness and Safety Issues Related To the Manufacturing Process
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00014
Issued / Original Publication Date: 2015-09-29
Summary Safety Review - REMICADE (infliximab) - Evaluating for the Risk of Cancer (Lymphoma, Hepatosplenic T-Cell Lymphoma, and Leukemia)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00015
Issued / Original Publication Date: 2015-09-29
Regulatory Decision Summary for SOMATULINE AUTOGEL
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00104
Product Type: Drug
Control Number: 178506
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-10-15
Decision / Authorization Date: 2015-09-28
Regulatory Decision Summary for Avastin
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00007
Product Type: Drug
Control Number: 171255
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-01-08
Decision / Authorization Date: 2015-09-28
Regulatory Decision Summary for Evotaz
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00018
Product Type: Drug
Control Number: 180673
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-02-27
Decision / Authorization Date: 2015-09-25
Regulatory Decision Summary for OPDIVO
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00036
Product Type: Drug
Control Number: 180828
DIN(s): 02446626, 02446634
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2014-12-19
Decision / Authorization Date: 2015-09-25
Regulatory Decision Summary for Zevtera
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00063
Product Type: Drug
Control Number: 178459
DIN(s): 02446685
Manufacturer: Basilea Pharmaceutica International AG
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-10-08
Decision / Authorization Date: 2015-09-24
Regulatory Decision Summary for Arnuity Ellipta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00006
Product Type: Drug
Control Number: 177319
DIN(s): 02446561, 02446588
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-08-19
Decision / Authorization Date: 2015-09-21
Regulatory Decision Summary for QNASL
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00041
Product Type: Drug
Control Number: 168323
DIN(s): 02446324, 02446332
Manufacturer: Teva Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-09-24
Decision / Authorization Date: 2015-09-18

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