News FAMHP

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Update on review of certain recalled lots of valsartan medicines

The European Medicines Agency (EMA) is conducting a review of the possible health effects in patients who may have taken certain lots of valsartan medicines containing an impurity called NDMA. This impurity was found in the active substance manufactured by Zhejiang Huahai Pharmaceuticals.

Request for information to the marketing authorisation holders for medicinal products for human use, in view of Brexit

The Federal Agency for Medicines and Health Products (FAMHP) wants to get a better view of all upcoming new MRPs (Mutual Recognition Procedures), DCPs (Decentralised Procedures) as well as of all RMS switches (Reference Member State) resulting from Brexit. Marketing authorisation holders are asked to provide the FAMHP with the necessary information as well as the information regarding the sites for which the UK is actually responsible.

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.

Surveys to measure the effectiveness of the e-PIL pilot project – the electronic Patient Information Leaflet replaces the paper Patient Information Leaflet

On 10 April 2018, the FAMHP launched a call for applications for the e-PIL pilot project, namely the project concerning the electronic Patient Information Leaflet. The effectiveness of the pilot project, or, in other words, the outcome of providing patient information in an electronic leaflet, will be studied using online surveys. The surveys will take place at the project’s launch, after 1 year, and after 2 years.

A symposium on working with and for patients - 25 September 2018

Patient participation throughout the development cycle of a medicinal product

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%.

Give your opinion on a clinical trial with a genetically modified medicinal product for the treatment of diabetes type 1

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: 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.

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