Traduction de «regulatory approval in april » (Néerlandais → Français) :

Exforge HCT, which adds a diuretic to this combination, was launched in the US after regulatory approval in April 2009 as a high blood pressure therapy with three medicines in one pill.
Exforge HCT, qui ajoute un diurétique à cette association, a été lancé aux Etats-Unis où il a été autorisé, en avril 2009, en tant que traitement contre l’hypertension associant trois médicaments en un comprimé unique.

Coartem (artemether/lumefantrine), the leading artemisinin-based combination treatment for malaria, received US regulatory approval in April.
Coartem (artéméther/luméfantrine), traitement combiné de pointe à base d’artémisinine contre le paludisme, a été homologué en avril aux Etats-Unis.

Exforge HCT, which includes the addition of a diuretic to this combination, received US regulatory approval in April 2009 as the only high blood pressure therapy with three medicines in one pill.
Exforge HCT, qui comprend l’adjonction d’un diurétique, a reçu en avril 2009 une autorisation au Etats-Unis en tant que seul traitement contre l’hypertension associant trois médicaments en un comprimé unique.

Japan (USD 0.7 billion, -4% cc) was impacted by a slowdown in demand ahead of the biennial price cuts in April, masking underlying momentum from the regulatory approvals of nine new medicines since 2009.
Le Japon (USD 0,7 milliard, -4% tcc) a été impacté par un ralentissement de la demande en prélude aux réductions bisannuelles de prix qui ont lieu en avril.

Pharmaceuticals – Betaseron ® On September 14, Novartis and Bayer Schering Pharma AG received regulatory approval to complete an agreement related to various rights for the multiple sclerosis treatment Betaseron ® under an earlier agreement between Schering and Chiron Corporation transferred to Novartis in April 2006.
Pharmaceuticals – Accord sur Betaseron ® lié à l’acquisition de Chiron Le 14 septembre, Novartis et Bayer Schering Pharma AG ont reçu l’autorisation des autorités de finaliser un accord portant sur différents droits du traitement contre la sclérose en plaques dénommé Betaseron ® qui avaient fait l’objet d’un accord antérieur passé entre Schering et Chiron Corporation, transféré en avril 2006 à Novartis.

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.

In February, this therapy for mild to moderate forms of Alzheimer’s disease dementia (approved in Europe) as well as dementia linked with Parkinson’s disease (approved in the US) was also submitted for regulatory approval in Japan.
Exelon/Exelon Patch est un traitement des formes légères à modérées de la maladie d'Alzheimer et de la démence associée à la maladie de Parkinson. La première indication a été autorisée en Europe et la seconde, aux Etats-Unis, tandis qu’une demande d’homologation a aussi été déposée en février au Japon.

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.