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Tag Archives: excipient

Use of ethanol in medicinal products: European Medicines Agency publishes guidance concerning safety information for the package leaflet

1.               Introduction On 22 November 2019, the European Medicines Agency (“EMA”) published an updated Annex to the European Commission’s Guidelines concerning excipients in the labelling and package leaflet of medicinal products for human use. This updated Annex provides a list of the excipients for which specific information should appear in the package leaflet. The list