English to German Medical Medical: Pharmaceuticals

XXX has a centralized license (which is probably the most demanding license available within the EU) and was assessed against the most up to date guidelines. The data the manufacturer generated in the EU supported a single dose and was accepted as being sufficient to allow the grant of this claim. If the data had been insufficient, the claim would not have been granted (and the EU authorities have a history of rejecting claims for new or existing products which do not have sufficiently compelling data).

Wouldn’t two doses be better?
In the EU, XXX has a single dose approval for this disease based on single dose treatment of EU cows under EU conditions. As XXX has been shown to work with one dose, there is no way the manufacturer would have been able to get a two dose claim in EU: this is how the regulatory system works.

Vielen Dank vorab! Ich denke mal, dass sich das nur umschreiben lässt ...