Aktualizace informací o přípravku u přípravků obsahujících ACE inhibitory

European regulatory authorities require an update of product information for medicines containing ACE inhibitors. This change stems from the results of the PSUSA procedure for the drugs piretanid/ramipril and piretanid. Marketing authorization holders must submit an application for a variation to the marketing authorization. The application can be of type IA IN, classified as C.3.a, or type IB, classified as C.3.b, if further text assessment is required. Implementation should occur as part of the next regulatory activity, ideally grouped with another "C" classification change. The latest deadline for implementation is one year from the publication of the recommendation. The goal is to harmonize information about these important medicines.