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February 18, 2019

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Category: Govt of Canada

Post-Authorization Activity Table (PAAT) for Ofev

Posted on February 11, 2019 by GetFit

Health Canada Post-Authorization Activity Table 2019-01-24, Ofev, 100 mg, 150 mg, nintedanib, capsule, oral, Boehringer…

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Regulatory Decision Summary for ORILISSA

Posted on February 11, 2019 by GetFit

Regulatory Decision Summaries (RDSs) explain Health Canada’s decisions for certain health products seeking market authorization.

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Post-Authorization Activity Table (PAAT) for Tafinlar

Posted on February 11, 2019 by GetFit

Health Canada Post-Authorization Activity Table 2019-01-15, Tafinlar, 50 mg, 75 mg, dabrafenib (as dabrafenib mesylate),…

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Summary basis of decision for Xermelo

Posted on February 11, 2019 by GetFit

Health Canada Summary Basis of Decision 2019-01-25. Xermelo, telotristat ethyl (as telotristat etiprate), 250 mg,…

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Post-Authorization Activity Table (PAAT) for Zepatier

Posted on February 11, 2019 by GetFit

Health Canada Post-Authorization Activity Table 2019-01-10, Zepatier, 50 mg elbasvir and 100 mg grazoprevir, tablet,…

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Summary Basis of Decision (SBD) for ALUNBRIG

Posted on February 11, 2019 by GetFit

Health Canada Summary Basis of Decision January 28, 2019. Alunbrig, brigatinib, 30 mg, 90 mg,…

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Post-Authorization Activity Table (PAAT) for Bexsero

Posted on February 11, 2019 by GetFit

Health Canada Post-Authorization Activity Table 2019-01-17, Bexsero, Recombinant Neisseria meningitidis serogroup B Neisseria Heparin Binding…

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Post-Authorization Activity Table (PAAT) for Bosulif

Posted on February 11, 2019 by GetFit

Health Canada Post-Authorization Activity Table 2018-12-20, Bosulif, 100 mg, 500 mg bosutinib, tablets, Pfizer Canada…

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Post-Authorization Activity Table (PAAT) for Cosentyx

Posted on February 11, 2019 by GetFit

Health Canada Post-Authorization Activity Table 2019-01-21, Cosentyx, 150 mg/mL, secukinumab, solution, Novartis Pharmaceuticals Canada Inc.

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Summary of Cancellation for Innohep Control number 199839

Posted on February 11, 2019 by GetFit

Device Class: Type of application: Application number: Medicinal ingredient(s): Therapeutic area: Type of submission: Control…

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