Letter to Health Care Professionals about the incorrect information on non-approved indication in the package information leaflet in English for the medicinal product Tyverb 250 mg film-coated tablets (lapatinib)
GlaxoSmithKline d.o.o., the marketing authorisation holder for the medicinal product Tyverb 250 mg film coated tablets (lapatinib), has in collaboration with the Agency for Medicinal Products and Medical Devices sent out a letter to health care professionals about the incorrect information on the indication in the patient information leaflet in English located in the package of the product Tyverb. The patient information leaflet in Croatian attached outside the package, contains accurate and approved indication as well as other information related to safe prescribing and use of Tyverb 250 mg film-coated tablets in Croatia.
Here you can view the text of the letter.
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.