1. November 29, 2022

    IFAPP Today newsletter - November/December 2022

    Source: IFAPP

    Please find here the link to the IFAPP TODAY newsletter of November/December 2022.

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  2. November 28, 2022

    Medical Affairs survey in collaboration with NVFG

    Fill out the survey aims to map, for the first time in Benelux, the Medical Affairs professional and collect insight on demographics, role & responsibilities, education and other aspects. Target audience are Medical Advisors, Medical Science Liaisons and other Medical Affairs professionals; active in Benelux.

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  3. November 24, 2022

    Coronavirus: overview of side effects of COVID-19 vaccines from November 24, 2022

    Meldingen van vermoedelijke bijwerkingen hebben bijgedragen tot een betere kennis van het veiligheidsprofiel van deze vaccins. Het FAGG blijft wil de melders bedanken en het melden van ernstige bijwerkingen blijven aanmoedigen om de vaccins beter te kunnen karakteriseren. Het FAGG heeft wel beslist om vanaf 2023 geen cumulatieve overzichten van gemelde bijwerkingen van COVID-19-vaccins meer te publiceren.

    Les notifications d’effets indésirables suspectés, rapportées notamment à l’AFMPS, ont participé à l’amélioration de la connaissance de leur profil de sécurité. L’AFMPS veut remercier les notificateurs et continue d’encourager la notification d’effets indésirables graves afin de mieux les caractériser. L’AFMPS a décidé d’arrêter la publication des aperçus cumulatifs des effets indésirables des vaccins contre la COVID-19 à partir de 2023. 

    Source: FAMHP

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  4. November 24, 2022

    Simultaneous national scientific advice pilot project: launch of phase 2

    The European Innovation Network (EU IN) has launched phase 2 of the simultaneous national scientific advice (SNSA) pilot project. SNSA can be used when an applicant wants to obtain national scientific advice from more than one national competent authority (NCA) at the same time. 

    Source: FAMHP

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  5. November 21, 2022

    PRAC November 2022 – Measures for Janus kinase inhibitors, modified product information of mRNA COVID-19 vaccines Comirnaty and Spikevax, and addition of warning to the product information for ustekinumab (Stelara)

    During its November 2022 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders. Furthermore, the PRAC recommended to add heavy menstrual bleeding to the product information as a side effect of the mRNA COVID-19 vaccines Comirnaty and Spikevax, and to add a warning to the product information for ustekinumab (Stelara).

    Source: FAMHP

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  6. November 8, 2022

    MedSafetyWeek 2022: annual campaign to promote adverse reactions reporting

    The global MedSafetyWeek runs from 7 to 13 November 2022. During this annual social media campaign, the FAMHP is also encouraging everyone to report suspected adverse reactions to medicinal products.

    Source: FAMHP

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  7. October 7, 2022

    PRAC October 2022 – New measures for terlipressin-containing medicines and change to product information for combination of medicines with codeine and ibuprofen

    During its October 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended new measures for terlipressin-containing medicines and has also recommended a change to the product information for codeine with ibuprofen combination medicines. The PRAC also discussed direct healthcare professional communications (DHPCs) containing important safety information for terlipressin-containing medicines and Imbruvica.

    Source: FAMHP

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  8. October 7, 2022

    Amended legislation: drug precursors added to list of scheduled substances

    The European Commission's new Delegated Regulation (EU) 2022/1518 adds two drug precursors to the list of scheduled substances. The regulation entered into force on 3 October 2022.

    Source: FAMHP

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  9. October 6, 2022

    IFAPP Today newsletter - October 2022

    Source: IFAPP

    Please find here the link to the IFAPP TODAY newsletter of October 2022.

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  10. October 3, 2022

    Flash VIG-news : Dispensation of pholcodine-containing medicinal products suspended due to the risk of allergic cross-reactivity with neuromuscular blocking agents

    Due to concerns about the risk of anaphylactic reactions, the dispensation of pholcodine-containing medicinal products is suspended from 1 October 2022.

    Source: FAMHP

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