Vertaling van "plans to file for approval " (Nederlands → Frans) :

Novartis plans to file for approval in this indication in the EU and other markets by the end of 2010.
Novartis prévoit de déposer, d’ici à la fin de l’année, des demandes pour cette indication dans l’UE et dans d’autres marchés.

Q4 2008 Approved - Clinical trials underway to address FDA Complete Response letter (October 2009); resubmission planned by end 2010 Approved Q4 2009 Q1 2010 - FDA approval received after priority review
- Feed-back des autorités attendu au T4 2010 T4 2008 Autorisé - Essais cliniques en cours pour répondre à la « complete response letter » de la FDA (T4 2009), nouvelle demande prévue avant fin 2010 Autorisé T4 2009 T1 2010 - Autorisation de la FDA après revue prioritaire

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.

Onbrez Breezhaler is now available in eight European markets, with further EU launches planned during 2010, and is approved in more than 40 countries worldwide.
Onbrez Breezhaler est maintenant disponible dans huit marchés européens, et d’autres lancements sont prévus en 2010 dans l’UE.

QAB149 COPD Q4 2008 Approved - Clinical trials underway to address FDA Complete Response letter (Q4 2009), resubmission planned for 2010
QAB149 BPCO T4 2008 Autorisé - Essais cliniques en cours pour répondre à la « complete response letter » de la FDA (T4 2009), nouvelle demande prévue en 2010

A dossier for EU approval of Afinitor (everolimus) in patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis was also filed in July 2010; the FDA granted everolimus priority review for this indication. The FDA action date is October 29.
contre l’astrocytome sous épendymaire à cellules géantes associé à une sclérose tubéreuse; la FDA a accordé à évérolimus le statut de revue prioritaire pour cette indication, et sa décision est attendue pour le 29 octobre.

- Japan filing achieved in July Approved Q4 2009 Q1 2010 - Positive Committee for Medicinal Products for Human Use (CHMP) opinion received in September
- Dépôt en juillet d’une demande au Japon Autorisé T4 2009 T1 2010 - Avis favorable émis en septembre par le Comité des médicaments à usage humain (CHMP)

First approvals of the Menveo meningitis vaccine in the US (February) and Europe (March) from age 11 and older, and also the US filing for use from age 2-10.
Les premières autorisations de Menveo, le nouveau vaccin contre la méningite, ont été accordées en février aux Etats-Unis et en mars en Europe pour son utilisation chez les enfants âgés de 11 ans et plus. Une demande a été déposée aux Etats-Unis pour les enfants de 2 à 10 ans.

plan toegang eurostation (File JPG)
plan acces eurostation (File JPG)

The brochure also forms part of a project file in execution of the national safety plan.
The brochure also forms part of a project file in execution of the national safety plan.