Review decisions

Showing 2210 results of 2627 total
Summary Safety Review - Sodium Glucose Cotransporter 2 (SGLT2) Inhibitors INVOKANA (canagliflozin) and FORXIGA (dapagliflozin) - Evaluation of a Potential Risk of Acute Kidney Injury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00062
Issued / Original Publication Date: 2015-10-16
Regulatory Decision Summary for Obizur
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00214
Product Type: Drug
Control Number: 177290
DIN(s): 02447401
Manufacturer: Baxalta Canada Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-08-15
Decision / Authorization Date: 2015-10-14
Regulatory Decision Summary for Amitiza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00001
Product Type: Drug
Control Number: 179333
Manufacturer: Sucampo Pharma Americas LLC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-10-31
Decision / Authorization Date: 2015-10-14
Regulatory Decision Summary for Gadovist
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00023
Product Type: Drug
Control Number: 179746
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-11-14
Decision / Authorization Date: 2015-10-14
Regulatory Decision Summary for GALEXOS
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00024
Product Type: Drug
Control Number: 179386
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-11-03
Decision / Authorization Date: 2015-10-08
Summary Basis of Decision for Eperzan
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00285
Product Type: Drug
Control Number: 165145
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-10-08
Updated Date: 2018-05-22
Regulatory Decision Summary for Kivexa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00029
Product Type: Drug
Control Number: 182186
Manufacturer: ViiV Healthcare ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-02-25
Decision / Authorization Date: 2015-10-02
Regulatory Decision Summary for ENTRESTO
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00016
Product Type: Drug
Control Number: 182734
DIN(s): 02446928, 02446936, 02446944
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-03-06
Decision / Authorization Date: 2015-10-02
Summary Basis of Decision for Empliciti
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00323
Product Type: Drug
Control Number: 188144
DIN(s): 02455919, 02455927
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-10-01
Issued / Original Publication Date: 2016-08-30
Decision / Authorization Date: 2016-06-21
Updated Date: 2024-11-22
Regulatory Decision Summary for Zerbaxa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00062
Product Type: Drug
Control Number: 178006
DIN(s): 02446901
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-09-15
Decision / Authorization Date: 2015-09-30

Displaying 2201 - 2210 of 2627 | Page 221 of 263
Date modified: