Hydrate is a substance that contains water in its formula and anhydrous is a substance that does not contain water. For non-hydrates, the word ‘anhydrous’ will be deleted from the titles of the monographs. According to Style Guide 2014 of the European Pharmacopoeia e.g. ‘Lactose, anhydrous’ will be written only as ‘Lactose’. The changes in the titles will be implemented for the 9th Edition and will therefore come into force on 1 January 2017.
The changes affect the summary of product characteristics, package leaflet, labelling and Module 3. The changes can be included e.g. as part of another variation impacting the SmPC and PL. Otherwise a Type IAIN A3 Change in name of the active substance or of an excipient should be submitted.
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