Dear applicants!
The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (PRAC EMA), having reviewed the available evidence from EudraVigilance and the literature on the association between the development of dysglycemia and the use of direct-acting antivirals intended for the treatment of hepatitis C, agreed that the registration certificate holders of direct-acting antivirals (Daklinza, Epclusa, Exviera, Harvoni, Maviret, Sovaldi, Viekirax, Vosevi, Zepatier) must, within 2 months (from the date; see the reference), amend the section “Special warnings and precautions for use” of the instruction for medical use by adding information on the risk of developing dysglycemia.
List of medicinal products containing direct-acting antiviral drugs and approved for medical use in Ukraine (according to the State Register of Medicinal Products as of 21.12.2018.
Linkhttps://www.ema.europa.eu/documents/prac-recommendation/prac-recommendations-signals-adopted-1-4-october-2018-prac-meeting_en.pdf
