Withdrawal of the marketing authorization only for the certain strength of the product

SIDC inform all marketing authorization holder that in case of a submitted application for withdrawal of the marketing authorization only for the certain strength of the product (registered by national procedure, MRP, DCP), where the summary of product characteristics and package leaflet are common to all strengths, is also required to submit a national variation for the remaining strengths namely type IB variation C.I.z - removal of text from the SPC (PIL), which relates to strength <mg>.

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