Spring Intro 2023

03/03/2023

Section 4.6 - Pregnancy and Lactation

Information should be given on any findings in the nonclinical testing which could be of relevance for the prescriber, especially data which is not included in other relevant sections of the SmPC. The information should be presented in a way that enables the prescriber to make use of any relevant findings that might apply to the use of the product in patients.

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Section 5.3 - nonclinical Safety Data Information should be given on any findings in the nonclinical testing which could be of relevance for the prescriber, especially data which is not included in other relevant sections of the SmPC. The information should be presented in a way that enables the prescriber to make use of any relevant findings that might apply to the use of the product in patients. Use Brief Qualitative Statements . Do Not include essays , Use Exposure Data not mg•kg -1 information. Do not try to include marketing data!

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