Traduction de «other important regulatory approvals » (Néerlandais → Français) :

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.

First quarter Novartis delivered a strong performance in the first quarter of 2010 – particularly the rapid expansion of recently launched products and important regulatory approvals achieved for new medicines and vaccines – as the Group made progress with a sharp focus on innovation, growth and productivity.
Premier trimestre Novartis a réalisé, au premier trimestre 2010, une forte croissance – due en particulier à l’expansion rapide des produits lancés récemment et aux autorisations importantes obtenues pour de nouveaux vaccins et médicaments – car le Groupe a progressé en se concentrant sur l'innovation, la croissance et la productivité.

Second quarter Novartis delivered a strong performance in the second quarter of 2010 – with the rapid expansion of recently launched products and important regulatory approvals achieved for new medicines – as the Group made progress on its agenda on innovation, growth and productivity.
Deuxième trimestre Novartis a réalisé, au deuxième trimestre 2010, une croissance due à l’expansion rapide des produits lancés récemment et aux autorisations importantes obtenues pour de nouveaux médicaments, tandis que le Groupe a progressé dans la réalisation de son programme ciblé sur l'innovation, la croissance et la productivité.

Other single-pill combinations in development are a combination of aliskiren and amlodipine, currently under regulatory review in the US and Europe, and a triple-combination therapy with aliskiren, amlodipine and a diuretic, expected to be submitted for US regulatory approval this year.
D’autres médicaments combinés en un comprimé unique sont en développement, tels que aliskirène et amlodipine, actuellement en cours d’examen aux Etats-Unis et en Europe, et une trithérapie avec aliskirène, amlodipine et un diurétique qu’il est prévu de soumettre cette année pour homologation aux Etats-Unis.

Other single-pill combinations in development are a combination of aliskiren and amlodipine, currently under regulatory review in the US and Europe, and a triple-combination therapy with aliskiren, amlodipine and a diuretic expected to be submitted for US regulatory approval in 2010.
D’autres médicaments combinés en un comprimé unique sont en développement, tels que aliskirène et amlodipine, actuellement encours d’examen aux Etats-Unis et en Europe, et une trithérapie avec aliskirène, amlodipine et un diurétique qu’il est prévu de soumettre en 2010 à homologation aux Etats-Unis.

Exjade, currently approved in more than 100 countries as the only once-daily oral therapy for transfusional iron overload, received regulatory approvals in 2009 in the US, Europe, Switzerland and other countries, extending the dose range to 40 mg/kg.
Exjade, actuellement homologué dans plus d’une centaine de pays en tant que seul traitement par voie orale en prise unique quotidienne contre une surcharge en fer transfusionnelle, a été autorisé en 2009 aux Etats-Unis, en Europe, en Suisse et dans d'autres pays pour élever le dosage à 40 mg/kg.

Exjade, currently approved in more than 100 countries as the only once-daily oral therapy for transfusional iron overload, received regulatory approvals in 2009 in the US, Europe, Switzerland and other countries extending the dose range to 40 mg/kg.
Exjade, actuellement homologué dans plus d’une centaine de pays en tant que seul traitement par voie orale en prise unique quotidienne contre une surcharge en fer transfusionnelle, a été autorisé en 2009 aux Etats-Unis, en Europe, en Suisse et dans d'autres pays pour élever le dosage à 40 mg/kg.

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.

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.