Traduction de «approvals have been » (Néerlandais → Français) :

Approvals have been received for up to six indications, including the treatment of osteoporosis in men and postmenopausal women.
Des autorisations ont été délivrées pour jusqu’à six indications, y compris le traitement de l’ostéoporose chez l’homme et chez la femme postménopausée.

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.

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.

The data in this source need, of course, to agree with those that have been approved or determined by the competent authority for marketing authorisation – MA (FAMHP), price (FPS Economy) and reimbursement modalities (RIZIV-INAMI), respectively.
The data in this source need, of course, to agree with those that have been approved or determined by the competent authority for marketing authorisation – MA (FAMHP), price (FPS Economy) and reimbursement modalities (RIZIV-INAMI), respectively.

This release contains forward-looking information about an agreement by Pfizer to acquire FoldRx, and about FoldRx’s product candidate tafamidis, its other clinical and preclinical development programs and its technology platform, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; whether and when a new drug application for tafamidis will be filed with the FDA; decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for tafamidis and that may be filed for any other product candidates that may be generated by FoldRx’s technology platform as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of tafamidis and such other product candidates; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.
Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; whether and when a new drug application for tafamidis will be filed with the FDA; decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for tafamidis and that may be filed for any other product candidates that may be generated by FoldRx’s technology platform as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of tafamidis and such other product candidates; and competitive developments.

Nevertheless, in view of the fact that this type of drink is already allowed in several European countries and taking into account the European regulations concerning this type of product, in the end, the competent French authorities have been obliged to give their approval (Decree of the European Court of Justice, Press release No. 12/04, 2004) for this beverage, which was marketed on 15 July 2008.
Néanmoins, considérant que ce type de boisson est déjà autorisé dans plusieurs pays d’européens et compte tenu de la réglementation européenne sur ce type de produit, les autorités compétentes françaises ont finalement dû l’autoriser (Arrêt de la Cour de Justice européenne, Communiqué de presse n° 12/04, 2004). Sa commercialisation a effectivement débuté en date du 15 juillet 2008.