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Vertaling van "approval is expected in " (Nederlands → Frans) :

European approval is expected in early 2010 after a positive opinion in December 2009, while a US regulatory decision is also expected in the first half of the year.

En Europe, une autorisation devrait être délivrée début 2010, après un avis favorable émis en décembre 2009, tandis qu’une décision est également attendue au premier semestre aux Etats-Unis.


This transaction, which requires customary regulatory approvals, is expected to be completed in 2009.

Cette transaction, qui nécessite les autorisations réglementaires usuelles, devrait être achevée en 2009.


The purchase of the 52% stake, which is subject to required regulatory approvals, is expected to be completed in the second half of 2010.

L’achat de la part de 52% devrait être finalisé au second semestre 2010, sous réserve de l’approbation des autorités réglementaires.


The formal EMA approval is expected by the end of this year.

L’autorisation formelle de l’EMEA est attendue pour la fin de cette année.


The late-stage pipeline is also progressing quickly: European regulatory approval expected soon for QAB149 (COPD), while further positive Phase III data presented in September 2009 reaffirmed the potential of FTY720 (MS).

Le pipeline de médicaments en phase ultime de développement progresse également avec rapidité. En effet, l’homologation de QAB149 (BPCO) est attendue sous peu tandis que de nouveaux résultats positifs de phase III présentés en septembre 2009 ont confirmé le potentiel de FTY720 (SEP).


In Japan, approvals of five new medicines to date in 2009 – Tasigna, Xolair, Co-Dio, Lucentis and Rasilez – are expected to underpin momentum in this important market.

Au Japon, l’homologation de cinq nouveaux médicaments à ce jour en 2009 – Tasigna, Xolair, Co-Dio, Lucentis et Rasilez – devrait donner une impulsion vigoureuse à ce marché important.


- Regulatory feedback expected in Q4 2010 Q4 2008 Approved Q3 2010 - Clinical trials to address US Food and Drug Administration (FDA) complete response letter (October 2009) completed in Q3 and data generated from these trials was submitted to the FDA in late September

2010 T4 2008 Autorisé T3 2010 - Essais cliniques pour répondre à la «complete response letter» de la FDA (oct. 2009) achevés au T3 et données soumises à fin septembre à la FDA


Advisory commission that is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (French-speaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacistsclinical biologists Commission for the supervision of advertising for medicines for human use

Advisory commission that is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (French-speaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacistsclinical biologists Commission for the supervision of advertising for medicines for human use


Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for h ...[+++]

Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for h ...[+++]


MRP IA: datum van implementatie zoals aangegeven in het antwoord op vraag 5.2 MRP IB: approval date van de RMS MRP II: approval date van de RMS

MRP IA : date d’implémentation telle qu’indiquée dans la réponse à la question 5.2 MRP IB : approval date du RMS MRP II : approval date du RMS




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Date index: 2021-05-01
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