"Hos patienter med mildt til moderat nedsat leverfunktion uden cholestasis bør valsartan - dosis ikke overstige 80 mg (jf. afsnit 4. 4)."
The wording proposed by the MAH in the SPC was acceptable to the CHMP and the following wording was adopted: “ In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4) .”