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Patient participation throughout the development cycle of a medicinal product

During its meeting of July 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of the cancer medicine Xofigo (radium-223 dichloride) to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments.

The results for 2017 confirm the trends of previous years with a reduced use of-7.4% mg active substance/kg biomass compared to last year. This is the biggest annual drop since 2011. Compared to the reference year 2011 it represents a total decrease of-25.9%.

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified medicinal product AG019 from the company Intrexon T1D Partners, LLC (IT1D). The purpose of this trial is to evaluate the safety, tolerability and potential activity of AG019, alone or in combination with teplizumab, for the treatment of diabetes mellitus type 1. The public consultation runs from 25 June 2018 to 25 July 2018 inclusive.

CESP (Common European Submission Portal), the European online system to exchange information between applicants of authorisations and competent authorities will have an update on 29 June 2018 to conform to the new General Data Protection Regulation (GDPR).

The abuse or intentional misuse of fentanyl-based medicinal products may result in overdose and/or death. Accidental overdose through the transfer or ingestion of patches can also be fatal.

De FOD VVVL en het FAGG nodigen u uit om deel te nemen aan de publieksraadpleging over een klinische proef met het genetisch gewijzigde geneesmiddel AG013 van de firma Oragenics. De proef dient om de veiligheid en werkzaamheid te beoordelen van AG013 voor de onderdrukking van orale mucositis bij patiënten met kanker van het hoofd en de hals die gelijktijdig radio- en chemotherapie krijgen. De publieksraadpleging loopt van 18 juni 2018 tot en met 18 juli 2018.

The company Bayer Pharma AG has decided to permanently withdraw the ESSURE ESS 305 sterilisation device from the market in the European Union, as of 30.05.2017. The manufacturer confirms that women already implanted with this device may continue to use it and that its preventative removal is not necessary for women who are not presenting any symptoms.

The telephone accessibility of the Call centre Marketing Authorisation of the FAMHP will change as from 1 June 2018. The Call centre Marketing Authorisation will answer your call between 9 AM and 1 PM.

During its meeting of May 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has confirmed its recommendation to suspend hydroxyethyl-starch (HES) solutions for infusion, has recommended new measures for Esmya, has finalised the review of Zinbryta and has issued precautionary advice on HIV medicine.