Vertaling van "regarding potential off-label " (Nederlands → Frans) :

The subpoena covered information regarding potential off-label marketing and promotion of TOBI, a treatment for patients with cystic fibrosis acquired through the purchase of Chiron Corporation in mid-2006.
Cette assignation couvrait des informations concernant l’éventualité d’une commercialisation et de promotion de TOBI, un traitement contre la fibrose cystique acquis lors de l'achat de Chiron Corporation à la mi-2006, pour des indications pour lesquelles ce produit n’a pas été autorisé.

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.

The subpoena covered information regarding potential off-label marketing and promotion of TOBI (tobramycin), a treatment for patients with cystic fibrosis acquired through the purchase of Chiron Corporation in mid-2006.
Cette assignation couvrait des informations concernant l’éventualité d’une commercialisation et de promotion de TOBI (tobramycine), un traitement contre la fibrose cystique acquis lors de l’achat de Chiron Corporation à la mi-2006, pour des indications pour lesquelles ce produit n’a pas été autorisé.

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.

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.

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.

Novartis is cooperating with parallel civil and criminal investigations of the US Attorney’s Office into allegations of potential off-label marketing and promotion of the epilepsy therapy Trileptal as well as certain payments made to healthcare providers in connection with this medicine.
Novartis coopère aux investigations civiles et criminelles que ce bureau mène en parallèle au sujet d’accusations de promotion de Trileptal, un traitement contre l’épilepsie, pour des indications pour lesquelles ce produit n’a pas été autorisé, et de certains paiements à des prestataires de soins de santé en lien avec ce médicament.

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.

Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory authorities in countries where regulatory applications for Prevenar 13 may be pending or may be submitted will approve such applications and their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.
This release contains forward-looking information that involves substantial risks and uncertainties regarding Prevenar 13, including its potential benefits; and the success of the AMC project for vaccines. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory authorities in countries where regulatory applications for Prevenar 13 may be pending or may be submitted will approve such applications and their decisions regarding labeling and other matters that could affect its availability or commercial potential; 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.