Traduction de «japan under the brand » (Néerlandais → Français) :

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.

Galvus was approved in Japan in January 2010 under the brand name Equa.
Galvus a été homologué en janvier 2010 au Japon sous la marque Equa.

Galvus was launched in Japan in April under the brand name Equa.
Galvus a été lancé en avril au Japon sous la marque Equa.

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.

More than 30 major regulatory approvals in 2009 included the new medicines Afinitor (cancer), Onbrez Breezhaler (chronic obstructive pulmonary disease) and Ilaris (CAPS); A (H1N1) pandemic flu vaccines; the first-ever biosimilars in Japan and Canada; and the Prevacid24HR OTC brand in the US.
Les plus de trente autorisations majeures obtenues en 2009 comprennent les nouveaux médicaments suivants: Afinitor (cancer), Onbrez Breezhaler (bronchopneumopathie chronique obstructive) et Ilaris (CAPS); les vaccins contre la pandémie de grippe A(H1N1); les premiers biosimilaires au Japon et au Canada ainsi que la marque Prevacid24HR en vente libre aux Etats-Unis.

Galvus and Eucreas, a single-pill combination of Galvus with metformin that accounts for the majority of sales, have outperformed a competitor medicine in the DPP-4 segment in some countries. Galvus was approved in Japan in January 2010 with the brand name Equa.
Galvus et Eucreas, un comprimé unique associant Galvus avec la metformine qui enregistre la majorité des ventes, ont surperformé dans certains pays un médicament concurrent dans le segment DPP-IV. Galvus a été homologué en janvier 2010 au Japon sous la marque Equa.

Zortress/Certican (USD 35 million, +19% cc), a transplantation medicine to prevent organ rejection in adult kidney and heart transplantation, continues to grow based on its availability in more than 80 countries and its US launch for adult kidney transplantation in April, 2010, under the brand name Zortress and is currently in two Phase III studies with global participation in heart transplantation, and also a worldwide study for liver transplantation.
Certican/Zortress (USD 35 millions, +19% tcc) est un médicament destiné à prévenir le rejet des organes dans les transplantations du rein et du cœur chez l’adulte.