1. July 28, 2022

    Call for Belgian laboratories to apply to become the European Union reference laboratory for in vitro diagnostic medical devices

    The European Commission has launched a call for laboratories of Member States to apply to become European Union reference laboratories (EURLs) for in vitro diagnostic (IVD) medical devices. The possible designation of such EURLs is provided for in article 100 of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

    Source: FAMHP

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  2. July 25, 2022

    IFAPP Today newsletter - July-August 2022

    Source: IFAPP

    Please find here the link to the IFAPP TODAY newsletter of July-August 2022.

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  3. July 25, 2022

    Unavailability of Caprelsa 100 mg 30 film-coated tablets: recommendations for specialist physicians and hospital pharmacists

    Het geneesmiddel Caprelsa 100 mg 30 filmomhulde tabletten, dat wordt gebruikt in de oncologie, zal van 26 juli 2022 tot 9 september 2022 onbeschikbaar zijn in België. Het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) doet daarom aanbevelingen.

    Le médicament Caprelsa 100 mg 30 comprimés pelliculés, utilisé en oncologie, sera indisponible en Belgique du 26 juillet 2022 au 9 septembre 2022. L'Agence fédérale des médicaments et des produits de santé (AFMPS) émet donc des recommandations.

    Source: FAMHP

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  4. July 14, 2022

    PRAC July 2022 – New measures for medicinal products containing nomegestrol or chlormadinone and start of assessment of neurodevelopmental disorders when using topiramate

    During its July 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA)  recommends new measures to minimise the risk of meningioma with medicines containing nomegestrol or chlormadinone. The PRAC also starts the review on the risk of neurodevelopmental disorders with topiramate.

    Source: FAMHP

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  5. July 5, 2022

    Antibiotics: amoxicillin for injection/infusion again available under the trade name Delamoxyle

    The availability of appropriate antimicrobial medicines is important to fight antimicrobial resistance. The FAMHP strives to keep or to bring essential antimicrobial products on the market and to keep healthcare professionals and patients well informed. Again, as a result of those efforts:  amoxicillin for injection/infusion has been back on the market in Belgium since April.

    Source: FAMHP

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  6. July 5, 2022

    The online medicinal products database gets an update

    The FAMHP online medicinal products database contains information on all medicinal products for human and veterinary use authorised in Belgium. Some new functions have been added in this new version. This makes it easier to search for new medicinal products or active ingredients.

    Source: FAMHP

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  7. June 30, 2022

    The FAMHP publishes its annual report for 2021: all figures and results, trends, activities related to COVID-19 and testimonials from our staff

    2021 was the year we gradually returned to our normal way of working at the FAMHP. The high workload caused by the pandemic remained present, but numerous other important projects awaited us, such as the implementation of several European legislations. In addition to the traditional facts and figures, the 2021 annual report includes testimonials that demonstrate the commitment and professionalism of our staff.  

    Source: FAMHP

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  8. June 23, 2022

    The FAMHP launches the Medicinal Product Management database: updating data in existing medicinal product databases temporarily not possible

    On 4th of July 2022, the FAMHP launches the Medicinal Product Management database, a new internal database for medicinal products. Due to the launch, it will be temporarily impossible to update the data in the existing medicinal product databases.

    Source: FAMHP

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  9. June 23, 2022

    Flash VIG-news: Nifuroxazide: important information on the use in pregnancy and lactation, mutagenicity and carcinogenicity

    Uit voorzorg mag nifuroxazide niet worden toegediend tijdens de zwangerschap en de borstvoeding.  Bij vrouwen die zwanger kunnen worden, mag nifuroxazide alleen worden gebruikt als zij effectieve anticonceptie gebruiken.

    Par mesure de précaution, le nifuroxazide ne doit pas être administré pendant la grossesse et l'allaitement. Le nifuroxazide ne doit être utilisé chez les femmes en âge de procréer que si elles utilisent une contraception efficace. 

    Source: FAMHP

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  10. June 23, 2022

    Sleeping pills: survey by the FAMHP shows that more than a third of patients show signs of dependence

    Meer dan achthonderd patiënten hebben deelgenomen aan een online bevraging van het FAGG over het gebruik van benzodiazepines en aanverwante geneesmiddelen bij slaapstoornissen. De bevraging toont aan dat de meeste patiënten deze geneesmiddelen te lang gebruiken. Meer dan een derde vertoont psychologische tekenen van afhankelijkheid. 

    Plus de huit cent patients ont participé à une enquête en ligne de l’AFMPS sur la consommation de benzodiazépines et de médicaments apparentés utilisés dans le cadre des troubles du sommeil. L’enquête montre que la plupart des patients consomment ces médicaments pendant trop longtemps. Plus d’un patient sur trois montre des signes de dépendance psychologique. 

    Source: FAMHP

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