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    The document discusses several modules related to clinical trials of Levemir combination with oral antidiabetic drugs (OADs). Module 2.5 provides a clinical overview of Levemir combination with OADs for pediatric use. Module 2.7.3 summarizes the clinical efficacy results from pediatric supplements. Module 2.7.4 summarizes the clinical safety results from pediatric supplements. Lastly, Module 2.7.6 describes the synopses of individual clinical studies.

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    Label Odner2

    Uploaded by

    erikaoktavianipurba
    5 views5 pages
    The document discusses several modules related to clinical trials of Levemir combination with oral antidiabetic drugs (OADs). Module 2.5 provides a clinical overview of Levemir combination with OADs for pediatric use. Module 2.7.3 summarizes the clinical efficacy results from pediatric supplements. Module 2.7.4 summarizes the clinical safety results from pediatric supplements. Lastly, Module 2.7.6 describes the synopses of individual clinical studies.

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    The document discusses several modules related to clinical trials of Levemir combination with oral antidiabetic drugs (OADs). Module 2.5 provides a clinical overview of Levemir combination with OADs for pediatric use. Module 2.7.3 summarizes the clinical efficacy results from pediatric supplements. Module 2.7.4 summarizes the clinical safety results from pediatric supplements. Lastly, Module 2.7.6 describes the synopses of individual clinical studies.

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    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as doc, pdf, or txt
    5 views5 pages

    Label Odner2

    Uploaded by

    erikaoktavianipurba
    The document discusses several modules related to clinical trials of Levemir combination with oral antidiabetic drugs (OADs). Module 2.5 provides a clinical overview of Levemir combination with OADs for pediatric use. Module 2.7.3 summarizes the clinical efficacy results from pediatric supplements. Module 2.7.4 summarizes the clinical safety results from pediatric supplements. Lastly, Module 2.7.6 describes the synopses of individual clinical studies.

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    of 5

    Module 2.

    5 Cinical Overview
    Levemir combination with OAD
    Clinical Overview :
    Pediatric Supplement
    Clinical Safety & Efficacy:
    Pediatric Supplement
    Module 2.7.3 Clinical Efficacy
    Levemir combination with OAD
    Module 2.7.4 Summary of Clinical
    Safety
    Module 2.7.4 Summary of Clinical
    Safety
    Module 2.7.6 Synopses of Individual
    Studies
    Nama Obat Jadi : NovoSeven 1.2; 2.4; 4.8 mg

    Produsen : Novo Nordisk A/S, Denmark

    Pendaftar : PT Anugrah Argon Medica, Palembang

    Nama Obat Jadi : NovoSeven 1.2; 2.4; 4.8 mg


    Pendaftar : PT Anugrah Argon Medica
    OBSOLETE LABELS
    Nama Obat Jadi : 1. Actrapid HM®; Penfill® Novolet®
    2. Mixtard 30 HM®; Penfill®; Novolet®
    3. Insulatard HM®; Penfill®; Novolet®

    Pendaftar : PT. Anugrah Argon Medica


    Palembang-Indonesia

    Produksi : Novo Nordisk A/S


    Bagsvaerd, Denmark

    Nama Produk : NovoPen 3

    Pendaftar : PT. Anugrah Argon Medica


    Palembang-Indonesia

    Produksi : Novo Nordisk A/S


    Bagsvaerd, Denmark

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