News FAMHP

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Give your opinion on a clinical trial with genetically modified vaccines developed for the treatment of hepatitis B

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified hepatitis B vaccines from the company GlaxoSmithKline Biologicals. The purpose of this trial is to evaluate the safety, the immunogenicity and the efficacy of hepatitis B candidate vaccines in adult patients with chronic hepatitis B. The public consultation runs from 24 July 2018 to 23 August 2018 inclusive.

PRAC July 2018 – Recommendation to restrict the use of prostate cancer medicine Xofigo

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.

CESP: updated privacy notice for GDPR

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).

Flash VIG-news: FENTANYL: reminder of appropriate use in order to minimize the risk of abuse, addiction or accidental overdose

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.

Give your opinion on a clinical trial with a genetically modified medicinal product against oral mucositis in patients with cancer

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.

New database for clinical trials in Belgium

The AFMPS has created an online database to hold information on all the clinical trials that it approves in Belgium and that have not yet been concluded. Healthcare professionals and patients will be able to use the database to query recruitment criteria of the clinical trials.

Flash VIG-news: PARACETAMOL - Reminder of the correct posology and precautions

The FAMHP reiterates the guidelines that were published in July 2014 about the correct posology and certain precautionary measures when using medicines based on paracetamol. The therapeutic indication of paracetamol is the symptomatic treatment of fever and pain.

Adaptation of RMA approval procedure

Following the amendment to Article 65quater of the Royal Decree of 14 December 2006, the procedure for approval of risk minimisation activities (RMA) has been adapted. Accordingly, the RMA evaluation and approval deadlines have also been adapted. Moreover, fees must now be paid for the submission of applications for approval.

Administrative simplification of the procedures for homoeopathic and (traditional) herbal medicines

From May 1, 2018 the FAMHP is simplifying a number of procedures for homoeopathic and (traditional) herbal medecines with the intention of streamlining the process and reducing the administrative load for companies and the government.

PRAC April 2018 - Risk of dosing errors with methotrexate and unmet medical need for hydroxyethyl-starch (HES) solutions for infusion

During its meeting of April 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review of the risk of dosing errors with methotrexate medicines. The PRAC decided to further consider unmet medical need for hydroxyethyl-starch (HES) solutions for infusion and will discuss its recommendation at its May 2018 meeting.

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