The European Pharmacopoeia Commission adopted a new monograph, on Rosuvastatin tablets (3008), at its 163rd session in March 2019. The monograph was published in Supplement 10.1 of the European Pharmacopoeia (Ph. Eur.), available since October 2019, and will become effective on 1 April 2020.
The monograph on Rosuvastatin tablets is the first on a multi-source medicinal product to have been adopted, and the product itself is one of the most widely used and prescribed medicines in the world. This monograph is the result of close co-operation between manufacturers, experts and the EDQM.
More information on how to read and apply the monograph may be found in the General principles for Monographs on Finished Products (FPs) containing chemically defined active substances.
The Ph. Eur. Commission has created a new group of experts (Group 17) to elaborate further monographs on multi-source products and their corresponding APIs. The members of this group were appointed at the 165th session of the Ph. Eur. Commission. The activities will start in early 2020, with nine products (immediate-release pharmaceutical forms, such as tablets, capsules, oral powder or oral suspension) and four active substances already on the work programme.