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.
Reporting side effects contributes to the monitoring of the safety of medicines. To stimulate patient reporting of side effects, there is now a user-friendly online reporting form available.
Detecting a dihydropyrimidine dehydrogenase (DPD) deficiency with validated screening tests before starting cancer treatment can contribute to a reduction in the toxicity of fluoropyrimidines.
Based on the publication of a number of scientific articles on metal-on-metal hip prostheses and the revisions of the recommendations in the United Kingdom regarding these, the FAMHP is revising its recommendations on the follow-up of patients with this type of prostheses.
The FAMHP is updating the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials in Belgium, with the introduction of a new option for sponsors willing to participate : the VHP plus.
The FPS Public Health and the FAMHP invite you to participate in the public consultation on two clinical trials with the genetically modified medicinal product AAV5-hFVIII-SQ (BMN 270) against hemophilia A. The public consultation runs from 27 February 2019 to 29 March 2019 inclusive.
After successful consideration among the FAMHP, the National Institute for Health and Disability Insurance (RIZIV-INAMI) and the manufacturer Therabel, the manufacturer has decided to continue to produce the drug Marevan. The FAMHP calls on pharmacists and patients to not order unnecessary inventories of the drug so that the drug will remain available for all patients.
The European Falsified Medications Directive came into effect on February 9, 2019. From that time most of the prescription and reimbursable medicines on the market must bear safety features. At each link in the distribution chain, the safety features must be checked so that the authenticity of the medicine upon delivery can be guaranteed.