Traduction de «regulatory authorities in countries » (Néerlandais → Français) :

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 information has also been submitted to European regulatory authorities.
Cette information a également été remise aux autorités réglementaires de l’Union européenne.

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.

The potential use of Zometa for adjuvant breast cancer in premenopausal women is being reviewed by US and European regulatory authorities with feedback anticipated by year end.
L’utilisation possible de Zometa en tant qu'adjuvant au traitement du cancer du sein chez les femmes préménopausées est actuellement examinée par les autorités réglementaires américaines et européennes dont un avis est attendu avant la fin de cette année.

US and Japanese regulatory authorities are also reviewing this data.
Les autorités réglementaires américaines et nippones sont également en train d’examiner ces données.

Omnitrope, the pioneering biosimilar of the recombinant human growth hormone somatropin, has received regulatory approval as the first-ever biosimilar in Japan under the brand name Somatropin BS S.C. This approval paves the way for greater access to high-quality biopharmaceuticals in the world’s second-largest pharmaceuticals market and comes about three months after Japanese authorities published guidelines for a biosimilar regulatory pathway, which is based on similar scientific principles already in place in the European Union.
Omnitrope, biosimilaire pionnier de la somatropine, une hormone de croissance humaine recombinante, a obtenu une autorisation au Japon sous la marque Somatropin BS S.C. Il s’agit du premier biosimilaire à avoir été homologué dans ce pays.

Exjade (USD 652 million, +27% lc), currently approved in more than 90 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 to extend the dose range to 40 mg/kg.
Exjade (USD 652 millions, +27% en m. l.), autorisé dans plus de 90 pays en tant que seul traitement par voie orale en prise unique quotidienne contre une surcharge en fer transfusionnelle, a été homologué 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.

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.