Lactose

This draft document supports the revision of the annex to the guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' with regard to lactose. It includes a proposal for updated information for the package leaflet.

Keywords: Excipients, package leaflet, lactose, glucose, galactose, galactosaemia

Current version

Draft information for the package leaflet regarding lactose used as an excipient in medicinal products for human use

Consultation dates: 19/11/2018 to 31/05/2019Draft: consultation closedReference Number: EMA/CHMP/186428/2016