MoH of Ukraine order No. 1391 of 22.12.2016 approved the package leaflets (hereinafter – the leaflet) of the original (reference) medicinal product containing dimetindene maleate and phenylephrine, namely the products VIBROCIL, nasal drops 15 ml in a vial No. 1, VIBROCIL, nasal spray 10 ml in a vial No. 1, VIBROCIL, nasal gel 12 g in a tube No. 1, with amendments and additions to the following sections of the leaflet: “Special warnings and precautions for use”, “Effects on ability to drive and use machines”, “Method of administration and doses”, “Overdose”.
List of medicinal products containing dimetindene maleate and phenylephrine authorized for medical use in Ukraine.
