Traduction de «medicine has been approved » (Néerlandais → Français) :

Results of a one-year study, which was undertaken in response to “approvable letters” from the FDA, achieved primary efficacy and renal function targets and were also consistent with experience seen in 70 countries – including in Europe – where this medicine has been approved.
Les résultats d’une étude d’un an, entreprise en réponse à des «approvable letters» émises par la FDA, a atteints ses objectifs principaux en termes d’efficacité et de fonction rénale. Ces résultats étaient également en adéquation avec les expériences récoltées dans 70 pays – notamment en Europe – où ce médicament est autorisé.

Everolimus is also the active ingredient in the anti-cancer therapy Afinitor, which has been approved in the US.
Evérolimus est aussi la substance active d'Afinitor, un traitement anticancer homologué aux Etats-Unis.

Extavia, the Novartis-branded version of Betaferon ® /Betaseron ® for relapsing forms of multiple sclerosis, was launched in the US in 2009, and since then has been approved in over 20 other countries.
Extavia, la marque de Novartis de la version de Betaferon ® /Betaseron ® contre les formes cycliques de la sclérose en plaques (SP), a été lancé en 2009 aux Etats-Unis et a été homologué depuis dans plus de vingt autres pays en 2010.

Extavia, the Novartis-branded version of Betaferon ® /Betaseron ® for relapsing forms of multiple sclerosis, was launched in the EU and US in 2009, and has been approved in over 30 countries.
Extavia, la marque de Novartis de la version de Betaferon ® /Betaseron ® contre les formes cycliques de la sclérose en plaques (SP), a été lancé en 2009 dans l’Union européenne et aux Etats-Unis et a été homologué depuis dans plus de trente pays.

NPC has been cooperating with parallel civil and criminal investigations by the EDPA into allegations of potential off-label marketing and promotion of the epilepsy therapy Trileptal as well as certain payments made to healthcare providers in connection with this medicine. Earlier this year, NPC entered into a plea agreement with the EDPA, which is contingent on court approval, to resolve criminal allegations.
NPC coopère aux investigations civiles et criminelles que l’EDPA mène en parallèle au sujet d’accusations de promotion de Trileptal, un traitement contre l’épilepsie, pour des indications pour lesquelles ce produit n’a pas été autorisé, et de certains paiements à des prestataires de soins de santé en lien avec ce médicament.

In anticipation of changes to the product portfolio in the US, which includes expected approvals for a number of new specialty medicines but also the loss of market exclusivity for Diovan and other medicines in the next few years, Novartis has further streamlined its US business in Pharmaceuticals to maximize the potential of the changing portfolio in both primary care and specialty markets.
Novartis anticipe les changements qui vont intervenir au cours des années à venir dans son portefeuille de produits aux Etats-Unis, notamment les autorisations attendues pour de nouvelles spécialités mais aussi la perte de l’exclusivité du marché pour Diovan et d’autres médicaments. C’est ainsi que Pharmaceuticals a encore rationalisé ses opérations américaines pour maximiser le potentiel d’un portefeuille en plein changement, à la fois dans les soins de santé primaires et dans les marchés des spécialités.

The latter has been designated as having expertise as an “Official Medicines Control Laboratory”, recognised by the FAMHP and the European Directorate for the Quality of Medicines (EDQM), for the monitoring of immunological products for veterinary use prior to marketing authorisation for the Belgian market.
The latter has been designated as having expertise as an “Official Medicines Control Laboratory”, recognised by the FAMHP and the European Directorate for the Quality of Medicines (EDQM), for the monitoring of immunological products for veterinary use prior to marketing authorisation for the Belgian market.

Lucentis (USD 377 million, +29% cc) has maintained strong growth reflecting its position as the only approved medicine to significantly improve vision in patients with wet age-related macular degeneration (AMD).
Lucentis (USD 377 millions, +29% tcc) a poursuivi sa forte croissance, car il est le seul médicament autorisé qui améliore de façon importante la vision des malades atteints de la forme exsudative de la dégénérescence maculaire liée à l’âge (DMLA).

If no comments have been received within this timeframe, it is tacitly assumed that the FAMHP has approved the commencement of the clinical trial.
If no comments have been received within this timeframe, it is tacitly assumed that the FAMHP has approved the commencement of the clinical trial.

Since 1 January 2007, the law has been in force requiring a preliminary approval for the payment by pharmaceutical companies or producers of medical devices of the participation costs of healthcare professionals in scientific events involving at least one night’s accommodation.
Since 1 January 2007, the law has been in force requiring a preliminary approval for the payment by pharmaceutical companies or producers of medical devices of the participation costs of healthcare professionals in scientific events involving at least one night’s accommodation.