Dette er det SPC, der var bilag til Europa- Kommissionens beslutning vedrørende denne artikel 7( 5) arbitreringssag vedrørende lægemidler indeholdende salmeterol/ fluticason.
In September 2001, the Marketing Authorisation Holders (MAHs) applied for a Type II variation through MRP to include chronic obstructive pulmonary disease (COPD) as a therapeutic indication for the fixed-dose combination of salmeterol/ FP 50/ 500 µg twice daily.