Dear Health Care Professional letter about the risk of dose-related hepatotoxicity associated with Valdoxan 25 mg film-coated tablets (apomelatin)
24.01.2013
The company Servier Pharma d.o.o., the marketing authorisation holder for Valdoxan 25 mg film-coated tablets (apomelatin) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals about several reports of serious liver injury associated with the use of the aforementioned medicinal product. The letter reminds health care professionals on the importance of monitoring of liver function tests in patients throughout their entire treatment.
Here you may view the letter to health care professionals (in Croatian).
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
