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    BSE Statement PD-0399 - Edition08.docxJan082024083305

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    suryadi.widjaya

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    BSE Statement PD-0399 - Edition08.docxJan082024083305

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    suryadi.widjaya
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    BSE Statement PD-0399_Edition08.docxJan082024083305

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    20 views1 page

    BSE Statement PD-0399 - Edition08.docxJan082024083305

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    suryadi.widjaya

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    BSE - Statement

    Published MasterControl documents frequently use JavaScript. If you are seeing this message, your viewer
    either does not support JavaScript or it is disabled. If you are using Adobe Acrobat, please enable JavaScript.
    If you are using another viewer, you will need to configure your browser to view PDF files externally in Adobe
    Acrobat. Product group: Lactose and Inhalation
    Brand name: Lactochem®, Lactohale®,
    Lactopress®, Pharmatose®,
    Respitose®, SuperTab®
    Document No.: PD-0399 Page 1 of 1

    Dear Customer,

    We herewith declare that our pharmaceutical grade lactose products have been produced from milk,
    that has been sourced from healthy cows in the same conditions as milk collected for human
    consumption. The sourcing of milk is supervised constantly by the competent authorities according
    to the EC milk hygiene Regulation 853/2004. Milk has been categorized by the Committee for
    Proprietary Medicinal Products (CPMP) and Committee for Veterinary Medical Products (CVMP) in
    its Guideline EMA/410/01 rev.3 as “Category IB: “Lower-infectivity tissues”.
    Our pharmaceutical grade lactose has been prepared, without the use of other ruminant material
    than calf rennet, according to the description as published in Public Statement EMEA/CPMP/571/02 of
    27 February 2002. This Public Statement was, among others, based on EMEA/CPMP/BWP/337/02 and
    states the following:
    “Taking all these factors and the scientific assessment performed by the Biotech Working Party into
    consideration, the Committee for Proprietary Medicinal Products (CPMP) concludes that
    the BSE-risk in pharmaceutical grade lactose is negligible.
    Therefore, our products mentioned above are considered safe regarding TSE.”

    Country/regulation specific BSE/TSE-Statements are available on request.

    This statement substitutes all previous versions issued for the brand names mentioned above.
    We trust this information, which is made up to the best of our knowledge, will be helpful to you.

    With kindest regards,

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