Dear Health Care Professional letter about the reports of Severe Cutaneous Adverse Reactions associated with the use of the medicinal product Incivo 375 mg, film-coated tablets (telaprevir)
The company Johnson & Johnson S.E. d.o.o., the marketing authorisation holder for the medicinal product Incivo 375 mg, film-coated tablets (telaprevir) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals about the risk of Severe Cutaneous Adverse Reactions (SCAR), associated with the use of the medicinal product Incivo. The letter reminds health care professionals on the current recommendations for the monitoring and treatment of skin adverse reactions listed in the Summary of Product Characteristics for Incivo 375 mg, film-coated tablets.
Here you may view the text of the letter (in Croatian).
HALMED has not received any adverse reaction report to the medicinal product Incivo 375 mg film-coated tablets. The Agency will continue to monitor the safe use of the product and will keep the public informed as new information becomes available.
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.