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Traduction de «use to extensive trials » (Néerlandais → Français) :

The R&D (research and development) department of the FAMHP is responsible for the evaluation and approval of clinical research activities, ranging from the first “use” (concept) to extensive trials with medicines that are developed and carried out by university and other research centres and by the pharmaceutical industry.

The R&D (research and development) department of the FAMHP is responsible for the evaluation and approval of clinical research activities, ranging from the first “use” (concept) to extensive trials with medicines that are developed and carried out by university and other research centres and by the pharmaceutical industry.


Extension is the result of a major amendment to the application to include an additional 12 months of data to provide a median of five years of follow up of the pivotal Austrian Breast & Colorectal Cancer Study Group Trial 12 (ABCSG-12) study.

Cette prolongation est le résultat d’une modification importante de la demande destinée à inclure des données portant sur douze mois de manière à fournir une moyenne sur cinq ans de suivi de l'essai pivot dénommé «Austrian Breast & Colorectal Cancer Study Group Trial 12» (ABCSG-12) sur le cancer du sein et du côlon.


The extension is the result of a major amendment to the application to include an additional 12 months of data to provide a median of five years of follow up of the pivotal Austrian Breast & Colorectal Cancer Study Group Trial 12 (ABCSG-12).

Cette prolongation est le résultat d’une modification importante de l’utilisation destinée à inclure des données portant sur douze mois de manière à fournir une moyenne sur cinq ans de suivi de l'essai pivot dénommé «Austrian Breast & Colorectal Cancer Study Group Trial 12» (ABCSG-12) sur le cancer du sein et du côlon.


Trials are underway examining the use of Tasigna in CML with suboptimal response to Glivec, as well as a Phase III trial in patients with GIST.

Des essais sont en cours pour étudier l’utilisation de Tasigna dans la LMC qui répond mal au Glivec, ainsi que des essais de phase III chez des malades atteints de GIST.


The FAMHP intends to significantly increase its involvement in the lifecycle of immunological medicines for veterinary use by providing scientific advice, evaluating applications for clinical trials in Belgium, adopting (co-)rapporteurships for CP, MRP and DCP for MA of vaccines for veterinary use and developing pharmacovigilance and inspection activities.

The FAMHP intends to significantly increase its involvement in the lifecycle of immunological medicines for veterinary use by providing scientific advice, evaluating applications for clinical trials in Belgium, adopting (co-)rapporteurships for CP, MRP and DCP for MA of vaccines for veterinary use and developing pharmacovigilance and inspection activities.


The database can be used to look up extensive information about authorised medicines without having to contact those responsible for providing information, as is currently the case ●● Healthcare professionals and veterinarians

The database can be used to look up extensive information about authorised medicines without having to contact those responsible for providing information, as is currently the case ●● Healthcare professionals and veterinarians


The compound patent, which covers the active ingredient, expires in March 2011 and a method of use patent expires in 2015, including pediatric extensions.

Le brevet de la molécule, qui couvre la substance active, expire en mars 2011 et celui qui a trait à sa méthode d’utilisation, en 2015, extensions pédiatriques incluses.


clinical trials with veterinary medicines and medical devices for veterinary use ●● Reduction of the backlogs for veterinary

clinical trials with veterinary medicines and medical devices for veterinary use ●● Reduction of the backlogs for veterinary


Trials are also underway examining the use of Tasigna in CML patients with suboptimal response to Glivec and in patients with metastatic GIST.

Des essais sont aussi en cours pour étudier l’utilisation de Tasigna dans la LMC chez des malades qui répondent mal au Glivec ainsi que chez malades atteints de GIST métastasique.


Trials are also underway examining the use of Tasigna in CML patients with suboptimal response to Glivec and in patients with metastatic and/or unresectable Kit+ GIST.

Des essais sont aussi en cours pour étudier l’utilisation de Tasigna dans la LMC chez des malades qui répondent mal au Glivec ainsi que chez des malades atteints de GIST métastasique et/ou à Kit+ non résectable.




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Date index: 2024-01-29
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