markedsføringstilladelsen har foreslået, er blevet vurderet på grundlag af den forelagte dokumentation og de faglige drøftelser i udvalget,
• the scope of the referral was the harmonisation of the Summaries of Products Characteristics, • the Summary of Products Characteristic, Labelling and Package Leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,