New practice for sodium in the product information
In the EMA document "Compilation of QRD decisions on stylistic matters in product information" (https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/compilation-quality-review-documents-decisions-stylistic-matters-product-information_en.pdf) a new, Europe-wide harmonised practice for oral/parenteral medicinal products containing less than 1 mmol sodium per dose was published.
In section 2 of the SmPC, there is no need to declare sodium, neither qualitatively nor quantitatively for oral/parenteral medicinal products containing less than 1 mmol sodium per dose. Section 3 of the labelling there is no need to declare sodium for oral medicinal products containing less than 1 mmol of sodium per dose.
The new practice is described in the document stilistische Belange.
