Review decisions

Showing 1320 results of 2294 total
Regulatory Decision Summary for Steglatro
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00404
Product Type: Drug
Control Number: 204724
DIN(s): 02475510, 02475529
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-04-13
Decision / Authorization Date: 2018-05-09
Regulatory Decision Summary for HADLIMA, HADLIMA PushTouch
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00386
Product Type: Drug
Control Number: 203250 & 203292
DIN(s): 02473097, 02473100
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-03-02
Decision / Authorization Date: 2018-05-08
Regulatory Decision Summary for Lynparza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00399
Product Type: Drug
Control Number: 210204
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-10-13
Decision / Authorization Date: 2018-05-08
Summary Basis of Decision for Skyrizi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00444
Product Type: Drug
Control Number: 215753
DIN(s): 02487454, 02519283, 02519291, 02532093, 02532107, 02546922
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-05-07
Issued / Original Publication Date: 2019-09-26
Decision / Authorization Date: 2019-04-17
Updated Date: 2024-09-23
Summary Safety Review - PRADAXA (dabigatran etexilate) - Assessing the potential risk of liver injury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00196
Issued / Original Publication Date: 2018-05-07
Regulatory Decision Summary for Bavencio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00362
Product Type: Drug
Control Number: 208742
DIN(s): 02469723
Manufacturer: EMD Serono, A Division of EMD Inc., Canada
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-08-24
Decision / Authorization Date: 2018-05-04
Regulatory Decision Summary for Imfinzi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00366
Product Type: Drug
Control Number: 208834
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-08-29
Decision / Authorization Date: 2018-05-04
Regulatory Decision Summary for Lynparza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00398
Product Type: Drug
Control Number: 205344
DIN(s): 02475200, 02475219
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-05
Decision / Authorization Date: 2018-05-04
Summary Safety Review - Gadolinium based contrast agents - Assessing the risk of gadolinium build-up in the brain and potential brain and nervous system (neurological) side effects
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00200
Issued / Original Publication Date: 2018-05-01
Regulatory Decision Summary for Mvasi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00368
Product Type: Drug
Control Number: 201427
DIN(s): 02470748, 02470756
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-12-29
Decision / Authorization Date: 2018-04-30

Displaying 1311 - 1320 of 2294 | Page 132 of 230
Report a problem or mistake on this page
Please select all that apply:
Date modified: