New PRAC recommendations cause changes in SPC wordings

There is a rather new EMA document containing wording that must be updated to product information of certain medicinal products: “Signaaleihin perustuvat PRACin suositukset valmistetietojen päivittämistä varten” / “PRAC recommendations on signals for update of the product information” (Hyväksytty 6.–9. tammikuuta 2015 PRACin kokouksessa).

You can find the document in Finnish here, and by changing the language code “fi_FI” to “en-GB” you get the English document.
The medicinal products concerned by this document are (in Finnish):
Atorvastatiini, fluvastatiini, lovastatiini, pitavastatiini,pravastatiini, simvastatiini; gadodiamidi; gadopenteettihappo,  gadoversetamidi, litium, paroksetiini, valoproaatti ja vastaavat lääkeaineet.
PRAC (Pharmacovigilance Risk Assessment Committee)  is “lääketurvatoiminnan riskinarviointikomitea” in Finnish.

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