From my translation from Russian:
The following safety information that may suggest changes in the benefit-risk ratio of the drug product is subject to expedited reporting to the regulatory bodies within 15 calendar days:
imposition of restrictions on the drug product’s distribution; market withdrawal; non-renewal, revocation or suspension of marketing authorization in the territory of other countries for safety- or efficacy-related reasons;
exceedance of the expected frequency of serious adverse reactions;
I feel that exceedance is stylistically wrong, it's a rare quaint word. What could be the alternative phrasing of this item in the list?
I thought of exceesive frequency but where to put the word expected, which is present in the Russian original?
So is there an alternative to the word "exceedance", a word or phrase with a noun function that has the same approximate meaning?
Maybe "violation of the upper limit of the expected frequency of serious adverse reactions?"