Aktualizace informací o přípravku u přípravků obsahujících inhibitory ACE

European regulatory authorities require an update to the product information for medicines containing ACE inhibitors. This change follows the results of the PSUSA procedure concerning the drugs piretanide/ramipril and piretanide. Marketing authorization holders must submit an application for a variation of the marketing authorization, type IA IN, classified as C.3.a. If further text assessment is required, the application may be type IB, classified as C.3.b. The implementation of these changes is mandatory as part of the next regulatory activity. Alternatively, it can be submitted as a standalone variation. The latest deadline for implementing these changes is one year from the publication of the recommendation. The aim is to harmonize information across all relevant medicines.