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Query about expedited reporting.

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  • Manoj Swaminathan
    11/10/2019 09:19
    A company markets Levothyroxine Injection in US and Levothyroxine Tablets in EU. Is there a need for cross-reporting serious adverse events associated with Levothyroxine Injection (US origin spont/lit ICSRs) to EU? I have seen people citing reference to GVP VI and stating that Levothyroxine Inj formulation is not marketed in EU by the MAH and hence there is no need for cross reporting.
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