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    EMA Grants ODD to GC Pharma's Hunterase ICV, for Mucopolysaccharidosis Type II
    EMA Grants ODD to GC Pharma's Hunterase ICV, for Mucopolysaccharidosis Type II

    01 Nov 2021

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20211101006010/en

    BUSINESSWIRE
    01 Nov 2021
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    Clinigen K.K., GC Pharma sign pact to market Hunterase ICV
    Clinigen K.K., GC Pharma sign pact to market Hunterase ICV

    04 Apr 2019

    // BIOSPECTRUMASIA

    https://www.biospectrumasia.com/news/50/13183/clinigen-k-k-gc-pharma-sign-pact-to-market-hunterase-icv.html

    BIOSPECTRUMASIA
    04 Apr 2019
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    Shire's Biological Idursulfase Receives Supplemental Approval in US
    Shire's Biological Idursulfase Receives Supplemental Approval in US

    22 Nov 2018

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125151

    FDA
    22 Nov 2018
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    List of centrally authorised products requiring a notification of a change for update of annexes
    List of centrally authorised products requiring a notification of a change for update of annexes

    12 Oct 2018

    // EMA

    https://www.ema.europa.eu/documents/regulatory-procedural-guideline/list-centrally-authorised-products-requiring-notification-change-update-annexes_en-0.pdf

    EMA
    12 Oct 2018
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