Review decisions

Showing 470 results of 633 total
Regulatory Decision Summary for Lovenox and Lovenox HP
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00446
Product Type: Drug
Control Number: 209807
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-09-29
Decision / Authorization Date: 2018-09-11
Regulatory Decision Summary for Nimenrix
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00595
Product Type: Drug
Control Number: 203844
Manufacturer: Pfizer Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-09-04
Decision / Authorization Date: 2018-09-02
Regulatory Decision Summary for Perjeta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00461
Product Type: Drug
Control Number: 209467
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-09-15
Decision / Authorization Date: 2018-08-30
Regulatory Decision Summary for Signifor LAR
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00433
Product Type: Drug
Control Number: 209345
DIN(s): 02480425, 02480433
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-09-19
Decision / Authorization Date: 2018-08-29
Regulatory Decision Summary for Arnuity Ellipta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00491
Product Type: Drug
Control Number: 208727
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-08-31
Decision / Authorization Date: 2018-08-16
Regulatory Decision Summary for Cimzia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00445
Product Type: Drug
Control Number: 209082
Manufacturer: UCB Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-09-01
Decision / Authorization Date: 2018-08-16
Regulatory Decision Summary for Bexsero
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00400
Product Type: Drug
Control Number: 209413
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-09-15
Decision / Authorization Date: 2018-08-14
Regulatory Decision Summary for Repatha
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00401
Product Type: Drug
Control Number: 208904
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-08-30
Decision / Authorization Date: 2018-08-10
Regulatory Decision Summary for Nucala
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00429
Product Type: Drug
Control Number: 208467
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-08-15
Decision / Authorization Date: 2018-07-17
Regulatory Decision Summary for Tresiba
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00384
Product Type: Drug
Control Number: 208917
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-09-08
Decision / Authorization Date: 2018-07-17

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