In connection with submitting a Swedish summary of product characteristics, it possible to make other changes to the SPC?
By way of exception, submitting a summary of product characteristics in Swedish can’t be combined with other variations (e.g. warnings for excipients or template updates). Only correction of minor individual mistakes is allowed.
In accordance with the grouping rules, other clinical variations can be grouped together in the same application. In this case, it is possible to make other variations as well.