CHMP mente, at bioækvivalensundersøgelsen (2207- 59- DOS- 5) viste ækvivalens i sikkerhedsprofilen, når produktet anvendes uden spacer, samt ensartede Cmax og Tmax værdier.
The CHMP was of the opinion that the bioequivalence study (2207-59-DOS-5) demonstrated equivalency in safety profile when used without a spacer, as well as similar Cmax and Tmax values.