Vertaling van "eu approvals in december " (Nederlands → Frans) :

Onbrez Breezhaler (QAB149, indacaterol) (USD 8 million) has demonstrated promising performance following EU approval in December 2009 as a once-daily long-acting beta-2 agonist (LABA) for adults with chronic obstructive pulmonary disease (COPD).
Onbrez Breezhaler (QAB149, indacaterol) (USD 8 millions) a enregistré une performance prometteuse après son homologation en décembre 2009 par l’UE en tant qu’antagoniste beta 2 à action prolongée en prise unique quotidienne pour les adultes souffrant de broncho-pneumopathie chronique obstructive (BPCO).

QAB149 (indacaterol) was submitted for US and EU approvals in December 2008 as a 24-hour bronchodilator for chronic obstructive pulmonary disease (COPD), an incurable condition in which the lungs have been damaged, usually from smoking.
QAB149 (indacatérol) a fait l’objet du dépôt d’une demande d’enregistrement aux Etats- Unis et en Europe en tant que broncho-dilatateur efficace durant 24 heures contre la broncho-pneumopathie chronique obstructive (BPCO), une maladie incurable qui conduit à une altération des poumons, causée habituellement par la fumée.

Glivec received European regulatory approval in May 2009 as a post-surgery (adjuvant setting) therapy for GIST following Swiss (February 2009) and US (December 2008) approvals.
Glivec a été homologué en mai 2009 par les autorités européennes comme traitement adjuvant postchirurgical contre les GIST, à la suite de la Suisse (février 2009) et des Etats-Unis (décembre 2008).

EU approval was received for Diovan in treating pediatric hypertension, following a positive CHMP opinion in December 2009.
L’homologation de Diovan par l’Union européenne (UE) pour le traitement de l’hypertension pédiatrique, à la suite d’un avis favorable du CHMP émis en décembre 2009.

In December 2009, Tasigna was submitted for US, European and other approvals worldwide for use in certain newly diagnosed chronic-phase CML patients based on data from the ENESTnd trial, the largest ever head-to-head comparison of a targeted therapy against Glivec.
Des demandes d’autorisations pour Tasigna ont été déposées, en décembre 2009, aux Etats-Unis, en Europe et dans d’autres pays en tant que traitement de certaines formes de LMC diagnostiquées précocement.

Onbrez Breezhaler (QAB149) (USD 3 million) a once-daily long-acting bronchodilator for adult patients with chronic obstructive pulmonary disease (COPD), was launched in Germany in December 2009 as well as Ireland and Denmark in March 2010 after European regulatory approval in November 2009.
Onbrez Breezhaler (QAB149) (USD 3 millions), un bronchodilatateur à action prolongée en inhalation unique quotidienne destiné aux adultes atteints de broncho-pneumopathie chronique obstructive (BPCO), a été lancé en Allemagne en décembre 2009 ainsi qu’en Irlande et au Danemark en mars 2010, après l’obtention de son autorisation en Europe en novembre 2009.

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.

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.

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

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 human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission
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 human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission