Vertaling van "first submission in europe " (Nederlands → Frans) :

Others include the first submission in Europe for MenB, which has the potential to become the first global vaccine against the B serogroup of meningococcal meningitis.
D’autres demandes comprennent la première soumission en Europe pour MenB qui est susceptible de devenir le premier vaccin au monde contre le sérogroupe B de la méningite à méningocoque.

Many development projects are progressing toward regulatory submissions in 2010, with up to five in oncology: two additional indications for Afinitor as well as first submissions for the development projects SOM230 (Cushing's disease), LBH589 (Hodgkin's lymphoma) and EPO906 (ovarian cancer).
Des demandes d’autorisation pour de nombreux projets en développement sont en voie d’être déposées en 2010, dont jusqu'à cinq en oncologie : deux indications supplémentaires pour Afinitor ainsi que les projets en développement SOM230 (maladie de Cushing), LBH589 (lymphome de Hodgkin) et EPO906 (cancer des ovaires).

The first submissions were previously planned for 2009, but were accelerated to December 2008 after data from two clinical studies showed adults and children achieved rapid and long-lasting clinical remission of symptoms of these diseases.
Prévues initialement en 2009, les premières demandes d’autorisation ont été avancées à décembre 2008, après que des résultats de deux études cliniques ont montré que les adultes et les enfants obtenaient rapidement des rémissions cliniques de longue durée des symptômes de ces maladies.

The first submission was made for ages 11-55.
La demande initiale d’enregistrement porte sur les classes d’âge de 11 à 55 ans.

Submission for EU approval of a triple-medicine combination therapy for hypertension in a single pill containing Tekturna/Rasilez, amlodipine and hydrochlorothiazide was achieved in May, following the US submission in the first quarter.
l’hypertension en un comprimé unique associant Rasilez/Tekturna, amlodipine et hydrochlorothiazide, dans la foulée d’un dépôt similaire au premier trimestre aux Etats-Unis.

Other important regulatory approvals in 2009 were received for the H1N1 pandemic flu vaccines in the US and Europe as well as the first-ever biosimilar in Japan and Prevacid 24HR, the first and only OTC version of this proton pump inhibitor in the US.
D’autres homologations importantes ont été reçues en 2009 pour les vaccins contre la pandémie de grippe H1N1 aux Etats-Unis et en Europe ainsi que pour le premier biosimilaire jamais produit au Japon et Prevacid 24HR, la première et unique version en vente libre de cet inhibiteur de la pompe à protons, aux Etats-Unis.

FTY720 (fingolimod), a novel oral development therapy for multiple sclerosis, is on track for regulatory submissions in the US and Europe by the end of 2009.
FTY720 (fingolimod), nouveau traitement par voie orale de la sclérose en plaques, est en bonne voie pour le dépôt de demandes d’homologation aux Etats-Unis et en Europe d’ici à fin 2009.

Compliance with the European directives on electronic submissions Compliance with the European directives requires a number of objectives to be achieved: ●● Arriving at a functional vision of communication standards with EMEA and the Member States in partnership with the industry and in line with European legislation ●● Standard project management, with important steps that are sponsored/supported by the Member States: first developing an IT infrastructure and then starting on a highly secure network followed by so-called “proofs of concept” in each field ●● Success depends above all on the FAHMP’s
Compliance with the European directives on electronic submissions Compliance with the European directives requires a number of objectives to be achieved: ●● Arriving at a functional vision of communication standards with EMEA and the Member States in partnership with the industry and in line with European legislation ●● Standard project management, with important steps that are sponsored/supported by the Member States: first developing an IT infrastructure and then starting on a highly secure network followed by so-called “proofs of concept” in each field ●● Success depends above all on the FAHMP’s