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Valproat-enthaltende Arzneimittel: Anhörung bei der EMA

25. September 2017 – Am 26. September 2017 findet eine öffentliche Anhörung bei der Europäischen Arzneimittelbehörde (EMA) zu Valproat-enthaltenden Arzneimitteln statt. Der Ausschuss für Risikobewertung im Bereich der Pharmakovigilanz (PRAC) der EMA führt dabei ein Risikobewertungsverfahren durch,  in welchem neben relevanten Interessensvertretern auch Vertreter der allgemeinen Öffentlichkeit über ihre Erfahrungen mit dem Arzneistoff Valproat (Valproinsäure) berichten.

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Topiramat-haltige Arzneimittel: Daten zum Risiko von kongenitalen Fehlbildungen, wie z.B. Lippen-/Gaumenspalten

18. April 2001 – Das Deutsche Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) hat kürzlich fogendermassen zu Topiramat-haltigen Arzneimitteln orientiert (siehe die originale Mitteilung hier):

Im Jahr 2009 wurde in einem europäischen Harmonisierungsverfahren eine differenzierte Nutzen-Risiko-Bewertung von topiramathaltigen Arzneimitteln vorgenommen und die Produktinformationen wurden überarbeitet.

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  • Distinct social profile and high ASD risk, 3q29 deletion survey finds July 19, 2019
    A survey of 93 people with 3q29 deletion syndrome reveals a distinct pattern of social disability and anxiety, even without a diagnosis of autism spectrum disorder. The results were published online in Molecular Autism on July 16.
  • Study sheds light on the darker parts of our genetic heritage July 19, 2019
    More than half of our genome consists of transposons,DNA sequences that are reminiscent of ancient, extinct viruses.Transposons are normally silenced by a process known as DNA methylation, but their activation can lead to serious diseases. Very little is known about transposons but researchers in an international collaboration project have now succeeded for the first time […]
  • Molecular cause for severe multi-organ syndrome July 19, 2019
    Three unrelated families on three continents (from continental Portugal, the United States and Brazil), all with healthy ancestors, had children with a very rare multi-organ condition that causes early-onset retinal degeneration, sensorineural hearing loss, microcephaly, intellectual disability, and skeletal dysplasia with scoliosis and short stature.
  • Researchers determine epigenetic origin of docetaxel-resistant breast cancer July 19, 2019
    Researchers at the Bellvitge Biomedical Research Institute (IDIBELL) have published a study in Molecular Cancer Research in which they identify methylation patterns associated with different subtypes of breast cancer, and a subclassification of the group of "triple negatives," a breast cancer type typically associated with poor prognosis. In addition, they identified changes in DNA methylation […]
  • Researchers report the function of reverse-twisting DNA July 19, 2019
    Normally, the two strands of the DNA double helix wind around each other in a right-handed spiral. However, there is another conformation called Z-DNA in which the strands twist to the left. The function of Z-DNA has remained a mystery since its discovery. A newly published paper unambiguously establishes that the Z-conformation is key to […]
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