Review decisions

Showing 870 results of 2304 total
Summary Safety Review - Methadone-Containing Products Used to Treat Opioid Dependence - Assessing the Potential Risk of Lack of Effect when Switching between Different Products
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00243
Issued / Original Publication Date: 2020-07-17
Regulatory Decision Summary for Fibryga
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00678
Product Type: Drug
Control Number: 230407
Manufacturer: Octapharma Pharmazeutika Produktionsges m.b.H.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-08-06
Decision / Authorization Date: 2020-07-16
Summary Basis of Decision for Rozlytrek
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00485
Product Type: Drug
Control Number: 227517
DIN(s): 02495007, 02495015
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-07-16
Regulatory Decision Summary for Tomvi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00694
Product Type: Drug
Control Number: 231245
DIN(s): 02498650
Manufacturer: Sterimax Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-08-30
Decision / Authorization Date: 2020-07-15
Regulatory Decision Summary for Xenleta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00767
Product Type: Drug
Control Number: 233292
DIN(s): 02501821, 02501848
Manufacturer: Sunovion Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-11-07
Decision / Authorization Date: 2020-07-10
Summary Basis of Decision for Daurismo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00483
Product Type: Drug
Control Number: 225793
DIN(s): 02498472, 02498480
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-07-10
Regulatory Decision Summary for Polivy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00713
Product Type: Drug
Control Number: 232303
DIN(s): 02499614
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-10-07
Decision / Authorization Date: 2020-07-09
Regulatory Decision Summary for SmofKabiven, SmofKabiven extra Nitrogen
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00787
Product Type: Drug
Control Number: 230147
DIN(s): 02501813
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-07-30
Decision / Authorization Date: 2020-07-09
Regulatory Decision Summary for Smofkabiven Electrolyte Free, Smofkabiven extra Nitrogen Electrolyte Free
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00794
Product Type: Drug
Control Number: 230307
DIN(s): 02501775
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-08-01
Decision / Authorization Date: 2020-07-09
Summary Safety Review - Brilinta (ticagrelor) - Assessing the Potential Risks of a Worsening of a Slow and Irregular Heartbeat (Bradyarrhythmia) and Partial or Complete Block in the Transmission of Heart Impulses (Second- and Third-Degree Atrioventricular Block)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00241
Issued / Original Publication Date: 2020-07-06

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