Traduction de «based on current standards » (Néerlandais → Français) :

The evaluation is based on current standards and guidelines on the quality, safety and clinical efficacy of medicines and health products.
The evaluation is based on current standards and guidelines on the quality, safety and clinical efficacy of medicines and health products.

The Production & Distribution department of the FAMHP is responsible firstly for overseeing the conformity to current standards, guidelines and legal requirements for the manufacture, distribution and dispensing of medicines and health products and secondly for granting authorisations, recognitions and certificates, as well as for combating illegal practices and monitoring pharmacies.
The Production & Distribution department of the FAMHP is responsible firstly for overseeing the conformity to current standards, guidelines and legal requirements for the manufacture, distribution and dispensing of medicines and health products and secondly for granting authorisations, recognitions and certificates, as well as for combating illegal practices and monitoring pharmacies.

EPO906 (ovarian cancer) was discontinued after a pivotal trial failed to achieve its primary end point in the form of improved overall survival over current standard of care (liposomal doxorubicin).
EPO906 (cancer des ovaires) a été arrêté après qu’un essai pivot a échoué à répondre à son critère principal d’efficacité sous la forme d’une amélioration globale du taux de survie par rapport au standard de soins courant (doxorubicine liposomale).

The drug has been shown previously to significantly reduce the relapse rate compared to intra-muscular interferon beta 1a, the current standard of care, and also to delay disability progression versus placebo.
Ce médicament a démontré sa capacité de réduire considérablement le taux de rechute comparé à l’interféron bêta 1a en injection intramusculaire, la norme actuelle de soin, et aussi de retarder la progression de l’invalidité par rapport à un placebo.

Unit cost: €2.53 Costs of interventions in current practice based on Dutch empirical data Cost calculations of interventions in increased implementation program based on Dutch practice guidelines and (for the duration of NRT and bupropion) on international trials (Cochrane meta-analysis) Costs of smoking-related diseases were taken into account, estimates based on Dutch cost-ofillness study that allocated total direct health care costs to diseases.
Unit cost: €2.53 Costs of interventions in current practice based on Dutch empirical data Cost calculations of interventions in increased implementation program based on Dutch practice guidelines and (for the duration of NRT and Buproprion) on international trials (Cochrane meta-analysis) Costs of smoking-related diseases were taken into account, estimates based on Dutch cost-ofillness study that allocated total direct health care costs to diseases.

Consistent with this focused research strategy, new Phase II data demonstrates that ACZ885, currently marketed as Ilaris for the rare disease cryopyrin-associated periodic syndrome (CAPS), provided highly statistically significant risk reduction of acute flares in gout patients compared to the anti-inflammatory standard of care.
Cette approche stratégique est illustrée par ACZ885, un médicament actuellement commercialisé sous la marque Ilaris pour traiter le syndrome périodique associé à la cryopirine (CAPS), une maladie rare. De nouveaux résultats d’une étude de phase II ont montré que ce médicament induisait une réduction importante, hautement significative sur le plan statistique, du risque de crises aiguës de goutte par comparaison avec le traitement anti-inflammatoire standard.

Lijst van de gebruikte afkortingen cGTP Current Good Tissue Practice EG Europese Gemeenschap EN Europese normen EU GMP European Union’s good manufacturing practice FDA Food and Drug Administration FMEA Failure Mode and Effects Analysis HACCP Hazard Analysis and Critical Control Points HEPA High-efficiency particulate air HGR Hoge Gezondheidsraad HVAC Heating, ventilation, and air conditioning ICSI Intra cytoplasmatische sperma injectie ISO International Organization for Standardization KB Koninklijk besluit KVE Kolonievormende eenheden MLM Menselijk lichaamsmateriaal NBN Nationale Belgische normen TSA Tryptic Soy Agar ULPA Ultra-low particulate air USP United States Pharmacopeia VS Verenigde Staten WHO World Health Organisation
Liste des abréviations utilisées AR Arrêté royal CE Communauté européenne cGTP Current Good Tissue Practice CSS Conseil Supérieur de la Santé EN European norms EU GMP European Union's good manufacturing practice FDA Food and Drug Administration FMEA Failure Mode and Effects Analysis HACCP Hazard Analysis and Critical Control Points HEPA High-efficiency particulate air HVAC Heating, ventilation, and air conditioning ICSI Injection intracytoplasmique de sperme ISO International Organization for Standardization MCH Matériel corporel humain NBN Bureau de Normalisation OMS Organisation mondiale de la santé TSA Tryptic Soy Agar UFC Unité formant colonie ULPA Ultra-low particulate air US United States USP United States Pharmacopeia

Based on an evaluation of publicly available information about Alcon during the first half of 2009, no factors indicated that the “value in use” of this strategic investment to Novartis has fallen below the current carrying value of USD 136.84 per share (The revised carrying value from the previous level of USD 140.58 at the end of the first quarter of 2009 takes into account dividends paid in 2009 as well as other equity accounting adjustments).
Sur la base d’une évaluation des informations publiées sur Alcon au cours du premier semestre 2009, aucun facteur n’indiquait que pour Novartis, la valeur d’utilité de cet investissement stratégique était tombée en dessous de la valeur comptable d’USD 136,84 par action (cette valeur comptable inscrite au bilan et révisée par rapport à la valeur d’USD 140,58 à la fin du premier trimestre 2009, suite aux dividendes payés en 2009 ainsi que d’autres ajustements comptables résultant de l’application de la méthode de la mise en équivalence).

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.

Intensive, community based, treatment teams for acute as well as for Workforce planning also requires information on the need/demand side, chronic physical conditions; information thatt is currently scarce.
Intensive, community based, treatment teams for acute as well as for Data on the need side chronic physical conditions; Workforce planning also requires information on the need/demand side,