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Submitting three strengths but planning to commercialize only two strengths

  • 1.  Submitting three strengths but planning to commercialize only two strengths

    This message was posted by a user wishing to remain anonymous
    Posted 15-Sep-2023 09:08
    This message was posted by a user wishing to remain anonymous

    My company is planning to include 3 strengths  in the M3 dossier for MAA, but only wish to commercialize two higher strengths but not the lower strength in EU.

    Does that impact in any way on the dossier writing for M3?



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