Review decisions

Showing 1970 results of 2627 total
Regulatory Decision Summary for Nanostim Leadless Cardiac Pacemaker
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00257
Product Type: Drug
Manufacturer: St. Jude Medical, Cardiac Rhythm Management Division
Date Filed / Submission Date: 2016-04-04
Decision / Authorization Date: 2016-11-22
Regulatory Decision Summary for HOLKIRA PAK
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00202
Product Type: Drug
Control Number: 190518
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-12-14
Decision / Authorization Date: 2016-11-21
Summary Basis of Decision for MDK-Nitisinone
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00336
Product Type: Drug
Control Number: 190564
DIN(s): 02457717, 02457725, 02457733, 02470055
Manufacturer: Mendelikabs Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-11-18
Updated Date: 2020-10-15
Regulatory Decision Summary for ADYNOVATE
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00188
Product Type: Drug
Control Number: 189709
DIN(s): 02459035, 02459043, 02459051, 02459078
Manufacturer: Baxalta Canada Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-12-02
Decision / Authorization Date: 2016-11-17
Summary Basis of Decision for Shingrix
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00377
Product Type: Drug
Control Number: 200244
DIN(s): 02468425
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-11-17
Issued / Original Publication Date: 2018-01-15
Decision / Authorization Date: 2017-10-13
Updated Date: 2024-08-23
Summary Safety Review - ZOFRAN (ondansetron) - Assessing the Potential Harm to the Fetus
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00135
Issued / Original Publication Date: 2016-11-16
Regulatory Decision Summary for HUMIRA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00194
Product Type: Drug
Control Number: 190514
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-12-14
Decision / Authorization Date: 2016-11-15
Summary Safety Review - DPP-4 inhibitors (gliptins) - Assessing the Potential Risk of Gastrointestinal Blockage (Gastrointestinal Obstruction)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00123
Issued / Original Publication Date: 2016-11-14
Summary Safety Review - Enlite Glucose Sensor- Assessing the Potential Risk of Improper Glucose Management
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00124
Issued / Original Publication Date: 2016-11-14
Summary Safety Review - Zelboraf (vemurafenib) - Assessing the Potential Risk of Bone Marrow Side Effects (Bone Marrow Toxicity or Suppression)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00139
Issued / Original Publication Date: 2016-11-14

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