Review decisions

Showing 1880 results of 2627 total
Regulatory Decision Summary for Erelzi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00226
Product Type: Drug
Control Number: 193864
DIN(s): 02462850, 02462869, 02462877
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-06-10
Decision / Authorization Date: 2017-04-06
Regulatory Decision Summary for Utrogestan
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00241
Product Type: Drug
Control Number: 180004
DIN(s): 02462818
Manufacturer: Besins Healthcare S A
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-12-03
Decision / Authorization Date: 2017-04-05
Regulatory Decision Summary for Vectibix
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00246
Product Type: Drug
Control Number: 193962
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-03-31
Decision / Authorization Date: 2017-04-05
Summary Safety Review - Avastin (bevacizumab) - Assessing the Potential Risk of Damage in Bones other than the Jawbone in Adult Cancer Patients
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00154
Issued / Original Publication Date: 2017-04-05
Regulatory Decision Summary for Multihance
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00430
Product Type: Drug
Control Number: 188279
Manufacturer: Bracco Imaging Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-10-06
Decision / Authorization Date: 2017-04-03
Regulatory Decision Summary for Metvix
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00258
Product Type: Drug
Control Number: 180975
Manufacturer: Galderma Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-12-24
Decision / Authorization Date: 2017-04-03
Summary Basis of Decision for Mictoryl/Mictoryl Pediatric
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00350
Product Type: Drug
Control Number: 188323
DIN(s): 02460262, 02460270, 02460289
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-04-03
Updated Date: 2019-12-12
Regulatory Decision Summary for Berinert 500/ Berinert 1500
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00224
Product Type: Drug
Control Number: 197440
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-08-19
Decision / Authorization Date: 2017-03-31
Summary Basis of Decision for Besponsa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00399
Product Type: Drug
Control Number: 204077
DIN(s): 02473909
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-03-30
Issued / Original Publication Date: 2018-08-22
Decision / Authorization Date: 2018-03-15
Updated Date: 2025-08-05
Regulatory Decision Summary for Tepadina
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00260
Product Type: Drug
Control Number: 168816
DIN(s): 02462680, 02462702
Manufacturer: Adienne SA
Submission Type: New Drug Submission
Date Filed / Submission Date: 2013-10-08
Decision / Authorization Date: 2017-03-29

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