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Why patient information leaflets have their place in informing patients about their medicines


I always thought that the wording PIL/MA was a part of the Product Licence application, and is tightly controlled by the MHRA/EMA, and could only be changed by going back to these authorities for any variation. I suspect some of the wording could be a bit too dogmatic/prescriptive. E.g. the PIL for Methotrexate tablets says 'do not take alcohol', or words to this effect, but this strong, unqualified, prohibition is not in the SPC/Data Sheet.

Posted date

18 DEC 2017

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