Vertaling van "us after regulatory approval in april " (Nederlands → Frans) :

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.

Afinitor (USD 12 million), an oral inhibitor of the mTOR pathway, was launched in the US after regulatory approval was granted in March as the first therapy for patients with advanced renal cell carcinoma (kidney cancer) after failure of treatment with sunitinib or sorafenib.
Afinitor (USD 12 millions), inhibiteur par voie orale de la voie mTOR, a été lancé aux Etats-Unis après avoir reçu, en mars, son homologation en tant que traitement du carcinome avancé des cellules rénales (cancer du rein) après échec d’un traitement par sunitinib ou sorafenib.

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.

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.

Extavia (USD 26 million), for patients with relapsing forms of multiple sclerosis (MS), was first launched in the European Union in early 2009 and is now available in more than 15 countries, including the US where it was launched recently after regulatory approval was granted in August 2009.
Extavia (USD 26 millions), pour les malades atteints de formes cycliques de sclérose en plaques (SEP), a été commercialisé d’abord dans l’Union européenne début 2009.

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.

European Union regulatory approval is anticipated soon, after the Committee for Medicinal Products (CHMP) issued a positive opinion in May supporting approval in renal cell carcinoma following progression on VEGF-targeted therapy.
Dans l’Union européenne, l’autorisation est attendue sous peu dès lors que le Committee for Medicinal Products (CHMP) a émis un avis favorable soutenant l’homologation dans le carcinome des cellules rénales à la suite de la progression du traitement ciblé sur le VEGF.