Review decisions

Showing 1650 results of 2627 total
Regulatory Decision Summary for Fucibet
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00442
Product Type: Drug
Control Number: 203765
DIN(s): 02474883
Manufacturer: Leo Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-03-10
Decision / Authorization Date: 2018-04-12
Regulatory Decision Summary for Xultophy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00359
Product Type: Drug
Control Number: 194513
DIN(s): 02474875
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-25
Decision / Authorization Date: 2018-04-11
Summary Safety Review - Atypical antipsychotics - Assessing the potential risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00198
Issued / Original Publication Date: 2018-04-10
Summary Safety Review - Sevoflurane - Re-Assessing the potential risk of slow heartbeat (bradycardia) in children with Down syndrome
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00197
Issued / Original Publication Date: 2018-04-09
Regulatory Decision Summary for Penthrox
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00391
Product Type: Drug
Control Number: 204879
DIN(s): 02474719, 02474727
Manufacturer: Purdue Pharma
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-20
Decision / Authorization Date: 2018-04-07
Regulatory Decision Summary for Tecentriq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00354
Product Type: Drug
Control Number: 205038
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-04-26
Decision / Authorization Date: 2018-04-06
Regulatory Decision Summary for Arbesda Respiclick
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00374
Product Type: Drug
Control Number: 197974
DIN(s): 02474611, 02474638, 02474646
Manufacturer: Teva Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-08-30
Decision / Authorization Date: 2018-04-06
Regulatory Decision Summary for Simponi I.V.
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00350
Product Type: Drug
Control Number: 205724
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-17
Decision / Authorization Date: 2018-04-05
Regulatory Decision Summary for Lapelga
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00357
Product Type: Drug
Control Number: 204841
DIN(s): 02474565
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-21
Decision / Authorization Date: 2018-04-05
Regulatory Decision Summary for Xgeva
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00367
Product Type: Drug
Control Number: 205235
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-02
Decision / Authorization Date: 2018-04-04

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