I indbringelsesskrivelsen anførte BfArM, at godkendelse af sådanne lægemidler kan medføre sundhedsrisiko, da uforligelighed mellem hjælpestoffet lactose i den valgte formulering og det aktive indholdsstof såvel som urenheder i selve det aktive indholdsstof kan give anledning til, at det færdige produkt indeholder urenheder, som det er muligt at undgå.
In their notification, the BfArM considered that the authorisation of these medicinal products may present a risk to public health due to the fact that the incompatibility between lactose as an excipient in the chosen formulation and the active substance, as well as impurities in the active substance itself lead to avoidable impurities in the finished product.