• Обучителна листовка • Кратка характеристика на продукта (КХП), и листовка и данни върху опаковката.
Prior to launch and as agreed with competent authorities in the Member States, the Marketing Authorisation Holder shall provide healthcare professionals in dialysis centres and retail pharmacies with the following: • Educational leaflet • Summary of product characteristics (SPC) and Package Leaflet and Labelling