The use of domperidone in newborns, infants, children (under 12) and adolescents weighing less than 35kg is no longer approved at European level. A new clinical study has demonstrated a lack of efficacy of the medical product.
The FAMHP has thoroughly prepared for Brexit in recent months and is ready to help and support the pharmaceutical industry and the medical devices industry before and after Brexit. The priority remains to prevent products becoming unavailable to patients.
The FAMHP has worked hard in recent months to guarantee that Belgian patients will have as few disadvantages as possible from Brexit. It has also taken various initiatives to prevent medicines becoming unavailable once Brexit has been completed. The impact may be greater for medical devices, but here too, preparations have been made to limit the consequences for the patient as much as possible.
The Vigilance Division of the FAMHP has found encoding errors in the article 57 database of the EMA. The FAMHP is asking holders of a marketing authorization for a medicine to carefully check that their registered data are correct.
EMA is advising healthcare professionals and patients not to exceed the recommended dose of Xeljanz (tofacitinib) when treating rheumatoid arthritis. The advice follows early results from an ongoing study (study A3921133) in patients with rheumatoid arthritis which showed an increased risk of blood clots in the lungs and death when the normal dose of 5 mg twice daily was doubled.
The FPS Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified medicinal product Talimogene Laherparepvec from the company Amgen. The purpose of this trial is to determine the safety and efficacy of talimogene laherparepvec in pediatric subjects with advanced non-central nervous system (CNS) tumors that are amenable to direct injection. The public consultation runs from 24 March to 24 April 2019 inclusive.
During its meeting of March 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review on screening patients before treatment with fluorouracil, capecitabine, tegafur and flucytosine.