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.

A new BelVet-Sac report confirms the declining use of antibiotics in livestock farming. Two of the three reduction targets have already been achieved.

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%.

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.

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.

Public hearing on quinolones and fluoroquinolones at EMA

The European Medicines Agency (EMA) is reviewing the quinolone and fluoroquinolone antibiotics. At its March 2018 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) decided that it would be of benefit to engage the wider EU public in this review.

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