Traduction de «regarding the other five products » (Néerlandais → Français) :

At this time, Novartis is unable to assess with any reasonable certainty the likely outcomes, which may be material, of the discussions regarding Trileptal or the inquiry regarding the other five products.
A ce stade, Novartis est dans l’impossibilité d’évaluer, avec un degré de certitude raisonnable, l’issue probable, susceptible d’être matérielle, des discussions concernant Trileptal ou les investigations sur les cinq autres produits.

NPC has also been cooperating with an investigation by the EDPA regarding potential off-label marketing and promotion as well as payments made to healthcare providers in connection with five other products, i.e. Diovan, Exforge, Sandostatin, Tekturna and Zelnorm (Five Products).
NPC a également coopéré à une enquête menée par l’EDPA au sujet d’accusations de promotion pour des indications pour lesquelles des produits n’ont pas été autorisés, et de paiements à des prestataires de soins de santé en lien avec cinq autres produits: Diovan, Exforge, Sandostatine, Tekturna et Zelnorm.

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.

Novartis is also cooperating with an inquiry by the EDPA regarding similar allegations of potential off-label marketing and promotion and payments to healthcare providers in connection with five other products: Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.
Novartis coopère également avec l’EPDA dans le cadre d’une enquête concernant des accusations similaires en relation avec cinq autres produits: Diovan, Exforge, Sandostatine, Tekturna et Zelnorm.

NPC is also cooperating with an investigation by the EDPA regarding potential off-label marketing and promotion as well as payments made to healthcare providers in connection with five other products, i.e.
NPC coopère également à une enquête de l’EDPA sur des accusations de commercialisation et de promotion ainsi que de paiements à des prestataires de soins de santé portant sur des indications pour lesquelles cinq autres produits n’ont pas été autorisés. Il s’agit de Diovan, Exforge, Sandostatine, Tekturna et Zelnorm.

NPC is also cooperating with an investigation by the EDPA regarding potential off-label marketing and promotion as well as payments made to healthcare providers in connection with five other products: Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.
NPC coopère également à une enquête menée par l’EDPA au sujet d’accusations de promotion pour des indications pour lesquelles des produits n’ont pas été autorisés, et de paiements à des prestataires de soins de santé en lien avec cinq autres produits: Diovan, Exforge, Sandostatine, Tekturna et Zelnorm.

As for D-glucuronolactone, the group believes that this concerns a normal human metabolite deriving from glucose, which does not involve a structural risk with regard to mutagenicity or carcinogenicity. It also holds that both this component as well as its hydrolysis product, glucuronic acid, are endogenous metabolites in humans and other mammals, that they are naturally present in various food sources and that they are quickly metabolised into innocuous products and excreted.
Pour la D-glucuronolactone, le groupe considère qu’il s’agit d’un métabolite humain normal provenant du glucose qui ne présente pas de risque structural en termes de mutagénicité ou de carcinogénicité, que pour ce composant, comme pour son produit d’hydrolyse, l’acide glucuronique, il s’agit de métabolites endogènes chez l’homme et les autres mammifères, qu’ils se trouvent à l’état naturel dans diverses sources alimentaires et qu’ils sont rapidement métabolisés en produits sans danger et excrétés.