PAR 1.92% 25.5¢ paradigm biopharmaceuticals limited..

I have been wondering about this too and I'm sure it is covered...

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    I have been wondering about this too and I'm sure it is covered off in earlier threads, but I went googling anyway.

    I managed to find a document produced by the Australian Department of Health titled:

    "Compounded medicines and good manufacturing practice (GMP) Guide to the interpretation of the PIC/S guide to GMP for compounded medicinal products" Version 3.0, September 2020

    It is here FYI: https://consultations.health.gov.au/tga/compounded-medicines-and-gmp/supporting_documents/consultationcompoundedmedicinesandgoodmanufacturingpracticegmp.DOCX

    This section appears relevant and would imply that Zilosul (once approved) would/should stop the compounding of injectable Elmiron

    Appropriate circumstances for compounding medicines

    Only prepare a compounded medicine in circumstances where:

    an appropriate commercial product is not available

    a commercial product is not suitable (e.g. if a patient experienced an allergy to an excipient in the commercial product), or

    when undertaking research sanctioned by a recognised human research ethics committee.

    The compounding of a medicine (whether prescribed or not) should not take place when it would both:

    be a close formulation to an available and suitable commercial product

    would not be likely to produce a different therapeutic outcome to the commercial product.

    In this situation, notify the prescriber that this medicine cannot be compounded under these circumstances.



    DYOR - my thoughts only ;-)
    Last edited by JamesTas: 20/08/21
 
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