Traduction de «new labeling was approved in europe » (Néerlandais → Français) :

The new labeling was approved in Europe in November, providing new guidance on the selection of appropriate myelodysplastic syndrome (MDS) and malignant disease patients for Exjade therapy.
Cette nouvelle notice a été approuvée en Europe en novembre; elle fournit de nouvelles recommandations au sujet de la sélection de malades appropriés souffrant du syndrome myélodysplastique et de maladies malignes susceptibles d’être traités avec Exjade.

In February, this therapy for mild to moderate forms of Alzheimer’s disease dementia (approved in Europe) as well as dementia linked with Parkinson’s disease (approved in the US) was also submitted for regulatory approval in Japan.
Exelon/Exelon Patch est un traitement des formes légères à modérées de la maladie d'Alzheimer et de la démence associée à la maladie de Parkinson. La première indication a été autorisée en Europe et la seconde, aux Etats-Unis, tandis qu’une demande d’homologation a aussi été déposée en février au Japon.

Menveo was also submitted in 2008 for regulatory approval in Europe for use in adolescents (from age 11) and adults.
Menveo a aussi été soumis aux autorités sanitaires européennes afin de recevoir une autorisation pour son utilisation chez les adolescents (à partir de 11 ans) et les adultes.

Afinitor, an oral inhibitor of the mTOR pathway, was launched in the US, Europe, Switzerland and Japan after first regulatory approvals in 2009 as a new treatment for advanced renal cell carcinoma (RCC, kidney cancer) following VEGF-targeted therapy.
Cet inhibiteur de la voie mTOR par administration orale, a été lancé aux Etats-Unis, en Europe, en Suisse et au Japon après avoir été homologué pour la première fois en 2009 comme nouveau traitement du carcinome avancé des cellules rénales (cancer du rein) à la suite d’un traitement ciblé sur le VGEF.

Over the past 12 months, we sustained our lead in approvals for new products, achieving more than 30 major new product approvals in the US, Europe and Japan.
Au cours des douze mois écoulés, nous avons conservé notre avance dans l’homologation de nouveaux médicaments, en obtenant plus de trente autorisations majeures de mise sur le marché de nouveaux produits aux Etats-Unis, en Europe et au Japon.

Gleevec/Glivec, a targeted therapy for certain forms of CML and GIST, was most recently approved in 2009 for use in adjuvant (post-surgery) GIST patients, with approvals now achieved in more than 55 countries in North America, Europe and Asia-Pacific.
L’autorisation la plus récente pour Glivec/Gleevec est celle délivrée en 2009 pour son utilisation en tant qu’adjuvant (post-chirurgical) chez les malades atteints de GIST. Il est maintenant homologué dans plus de 55 pays en Amérique du Nord, en Europe et en Asie-Pacifique.

The latest approval was for use in adjuvant (post-surgery) GIST patients, which is now approved in more than 25 countries in North America, Europe and Asia-Pacific.
La dernière autorisation a porté sur son utilisation en tant qu’adjuvant postchirurgical chez les malades atteints de GIST. Il est maintenant homologué dans plus de 25 pays en Amérique du Nord, en Europe et en Asie-Pacifique.

This release contains forward-looking information about an agreement by Pfizer to acquire FoldRx, and about FoldRx’s product candidate tafamidis, its other clinical and preclinical development programs and its technology platform, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; whether and when a new drug application for tafamidis will be filed with the FDA; decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for tafamidis and that may be filed for any other product candidates that may be generated by FoldRx’s technology platform as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of tafamidis and such other product candidates; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.
Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; whether and when a new drug application for tafamidis will be filed with the FDA; decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for tafamidis and that may be filed for any other product candidates that may be generated by FoldRx’s technology platform as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of tafamidis and such other product candidates; and competitive developments.