2, i direktiv 2001/ 83/ EF, med senere ændringer, da produktresuméet for ovennævnte lægemiddel ikke er det samme i alle EU- medlemsstater, Island og Norge.
Diovan was included in the list of products for Summary of Products Characteristics (SPC) harmonization, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/ 83/ EC, as amended, as the above-mentioned medicinal product does not have the same SPC across all EU Member States, Iceland and Norway.