Traduction de «european union approval was granted » (Néerlandais → Français) :

European Union approval was granted in August 2009 for use in children age 6-11 suffering from severe persistent allergic asthma.
L’Union européenne l’a autorisé en août 2009 pour son utilisation chez les enfants âgés de 6 à 11 ans souffrant d’asthme allergique persistant sévère.

An industry leader in new product approvals, Novartis achieved US and European Union approvals in the first quarter for Menveo, a new vaccine offering protection against four major serogroups of meningococcal meningitis, a potentially fatal bacterial disease.
Parmi les leaders de l’industrie en ce qui concerne les autorisations pour de nouveaux produits, Novartis a obtenu, au premier trimestre 2010, l’homologation de Menveo aux Etats-Unis et dans l’Union européenne. Il s’agit d’un nouveau vaccin qui protège contre les quatre principaux sérogroupes de méningite à méningocoque, une maladie bactérienne potentiellement mortelle.

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.

Reclast/Aclasta, approved for five indications, gained additional US approval in May as the only therapy to prevent postmenopausal osteoporosis with convenient, less-frequent dosing, while European approval was granted in June for treatment of osteoporosis caused by steroid treatment in men and postmenopausal women, an indication already approved in the US.
Autorisé pour cinq indications, Aclasta/Reclast a obtenu en mai des autorisations supplémentaires aux Etats-Unis en tant que seul traitement pratique et peu fréquent destiné à prévenir l’ostéoporose postménopausique. En Europe, l’autorisation a été accordée en juin pour le traitement de l’ostéoporose provoquée par des stéroïdes chez l’homme et la femme postménopausée, indication déjà homologuée aux Etats-Unis.

Other approvals include Afinitor (cancer) in the US and European Union as well as the US approvals of the new biotechnology drug Ilaris (CAPS) and Extavia (multiple sclerosis) as well as the high blood pressure combination therapies Valturna, Exforge HCT and Tekturna HCT.
Les autres autorisations comprennent Afinitor (cancer) aux Etats-Unis et dans l’Union européenne ainsi que Ilaris (CAPS), un nouveau médicament biotechnologique, Extavia (sclérose en plaques) et les traitements combinés contre l’hypertension Valturna, Exforge HCT et Tekturna HCT aux Etats-Unis.

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.

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.

Hierbij kan worden opgemerkt dat het RIZIV mede-organisator was van het colloquium over “the influence of EU law on the social character of health care systems in the European Union” dat in het kader van het Belgische voorzitterschap van de Europese Unie werd georganiseerd op 7 en 8 december 2001;
A cette occasion, remarquons la collaboration de l’INAMI à l’organisation du colloque relatif à l’« influence of EU law on the social character of health care systems in the European Union », organisé les 7 et 8 décembre 2001 dans le cadre de la présidence belge de l’Union européenne;

On 23 December 2005, approval was granted by the Council of Ministers for the establishment of an autonomous medicines agency: the Federal Agency for Medicines and Health Products or FAMHP.
On 23 December 2005, approval was granted by the Council of Ministers for the establishment of an autonomous medicines agency: the Federal Agency for Medicines and Health Products or FAMHP.

It is also essential for rational and safe use of medicines that the information in advertising agrees with the elements approved of when the marketing authorisation (MA) for the medicine was granted. Healthcare professionals when making a therapeutic choice should not be influenced by elements that are not associated with the characteristics of the medicine.
It is also essential for rational and safe use of medicines that the information in advertising agrees with the elements approved of when the marketing authorisation (MA) for the medicine was granted. Healthcare professionals when making a therapeutic choice should not be influenced by elements that are not associated with the characteristics of the medicine.