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Combating winter medicine shortages: launch of the 2024-2025 winter plan

  • Post author:
  • Post published:18/11/2024
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Nous activons pour la deuxième année consécutive un plan hivernal afin d’anticiper, suivre et gérer les éventuelles pénuries touchant des médicaments majeurs de l’hiver. Ce dispositif vise à sécuriser la…

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European regulation on clinical trials of medicinal products: end of the transition period

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  • Post published:18/11/2024
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Le règlement européen n°536/2014 relatif aux essais cliniques de médicaments (REC) est entré en vigueur depuis le 31 janvier 2022, abrogeant la directive 2001/20/CE (directive EC).Pendant trois ans, du 31…

Continue ReadingEuropean regulation on clinical trials of medicinal products: end of the transition period

Feedback on the October 2024 PRAC (September 30 – October 3)

  • Post author:
  • Post published:17/11/2024
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Le comité de pharmacovigilance (PRAC) de l’Agence européenne des médicaments (EMA) a initié une réévaluation de la balance bénéfice/risque des médicaments contenant du finastéride ou du dutastéride, suite à des…

Continue ReadingFeedback on the October 2024 PRAC (September 30 – October 3)

Oxbryta (voxelotor): what to do following suspension of marketing authorisation

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  • Post published:17/11/2024
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La Commission européenne a suspendu l’autorisation de mise sur le marché (AMM) du médicament Oxbryta (voxelotor) sur recommandation du Comité des médicaments à usage humain (CHMP) de l’Agence européenne (EMA).…

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Praluent: conduct to adopt in a context of supply tension

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  • Post published:17/11/2024
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Actualisation du 11/10/2024Les fortes tensions en Praluent (alirocumab) touchent désormais tous les dosages : 75 mg, 150 mg et 300 mg. Afin de permettre la continuité de traitement des patients…

Continue ReadingPraluent: conduct to adopt in a context of supply tension
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