The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new monograph on Rosuvastatin tablets (3008) at its 163rd session (March 2019). The monograph will be published in the 1st supplement to the 10th Edition (available in October 2019) and will become effective on 1 April 2020.
Rosuvastatin tablets is the first monograph on a multi-source medicinal product to have been adopted and the product itself is one of the most widely used and prescribed medicines. This monograph is the result of a close cooperation between manufacturers, experts and the EDQM.
More information on how to read and apply the monograph could be found in the General principles for monographs on finished products (FPs) containing chemically defined active substances.