Review decisions

Showing 2260 results of 2627 total
Summary Safety Review - Combined Hormonal Birth Control Products - Evaluating effectiveness when used by women who are obese
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00021
Issued / Original Publication Date: 2015-07-23
Regulatory Decision Summary for Ziagen
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00064
Product Type: Drug
Control Number: 176901
Manufacturer: ViiV Healthcare ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-08-01
Decision / Authorization Date: 2015-07-21
Summary Basis of Decision for Zydelig
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00205
Product Type: Drug
Control Number: 172652
DIN(s): 02438798, 02438801
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-07-20
Updated Date: 2021-11-22
Regulatory Decision Summary for Viibryd
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00058
Product Type: Drug
Control Number: 176820
DIN(s): 02443732, 02443740, 02443759
Manufacturer: Forest Laboratories Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-07-29
Decision / Authorization Date: 2015-07-16
Regulatory Decision Summary for Cyramza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00013
Product Type: Drug
Control Number: 176810
DIN(s): 02443805
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-07-28
Decision / Authorization Date: 2015-07-16
Regulatory Decision Summary for EPERZAN
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00017
Product Type: Drug
Control Number: 165145
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2013-05-23
Decision / Authorization Date: 2015-07-15
Regulatory Decision Summary for Vibativ
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00005
Product Type: Drug
Control Number: 176895
Manufacturer: Pendopharm, Division of Pharmascience Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-08-01
Decision / Authorization Date: 2015-07-14
Summary Safety Review - Acetaminophen - Liver Injury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00120
Issued / Original Publication Date: 2015-07-09
Summary Basis of Decision for Cinqair
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00331
Product Type: Drug
Control Number: 185873
DIN(s): 02456419
Manufacturer: Teva Canada Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-07-03
Issued / Original Publication Date: 2016-10-25
Decision / Authorization Date: 2016-07-20
Updated Date: 2024-02-09
Summary Safety Review - FERAHEME (ferumoxytol) - Serious allergic reactions (Hypersensitivity reactions)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00023
Issued / Original Publication Date: 2015-07-03

Displaying 2251 - 2260 of 2627 | Page 226 of 263
Date modified: