Traduction de «form » (Néerlandais → Français) :

A further list and description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and in its reports on Form 10-Q and Form 8-K. # # # # #
A further list and description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and in its reports on Form 10-Q and Form 8-K.

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.

1974 on the opening, transfer and merger of retail pharmacies Royal decree of 9 July 1984 on the provision of information and advertising relating to medicines Royal decree of 11 January 1993 determining the conditions under which medicines for human use may be supplied in sample form Royal decree of 7 April 1995 on the provision of information and advertising relating to medicines for human use Royal decree of 15 July 1997 on active implantable medical devices, transposing Directive 90/385 EEC (AIMD) Royal decree of 19 December 1997 on the control and analysis of the raw materials used by dispensing chemists Royal decree of 18 March 1999 on medical devices, transposing Directive 93/42/EEC of 14 June 1993 (MDD) Royal decree of 11 July 2003 determining the conditions under which medicines for veterinary use may be supplied in sample form Law of 16 December 2004 modifying the regulations on combating abuses in the promotion of medicines Royal decree of 10 June 2006 establishing the report point referred to in Article 10, § 5, of the law of 25 March 1964 on medicines Royal decree of 23 November 2006 implementing Article 10, § 3, of the law of 25 March 1964 on medicines Royal decree of 25 February 2007 recognising the institutions referred to in Article 10 § 3 of the law of 25 March 1964 on medicines
1974 on the opening, transfer and merger of retail pharmacies Royal decree of 9 July 1984 on the provision of information and advertising relating to medicines Royal decree of 11 January 1993 determining the conditions under which medicines for human use may be supplied in sample form Royal decree of 7 April 1995 on the provision of information and advertising relating to medicines for human use Royal decree of 15 July 1997 on active implantable medical devices, transposing Directive 90/385 EEC (AIMD) Royal decree of 19 December 1997 on the control and analysis of the raw materials used by dispensing chemists Royal decree of 18 March 1999 on medical devices, transposing Directive 93/42/EEC of 14 June 1993 (MDD) Royal decree of 11 July 2003 determining the conditions under which medicines for veterinary use may be supplied in sample form Law of 16 December 2004 modifying the regulations on combating abuses in the promotion of medicines Royal decree of 10 June 2006 establishing the report point referred to in Article 10, § 5, of the law of 25 March 1964 on medicines Royal decree of 23 November 2006 implementing Article 10, § 3, of the law of 25 March 1964 on medicines Royal decree of 25 February 2007 recognising the institutions referred to in Article 10 § 3 of the law of 25 March 1964 on medicines

Narcotics forms The graph below shows the fluctuation in the number of narcotics forms issued per month.
Narcotics forms The graph below shows the fluctuation in the number of narcotics forms issued per month.

Créée sous la forme d’un groupe informel de travail réunissant essentiellement des hôpitaux bruxellois depuis 1998, la plate-forme régionale d’hygiène hospitalière Bruxelles-Brabant wallon fédère, depuis l’automne 2002, les médecins et les infirmiers hygiénistes de 56 hôpitaux de la région bruxelloise, du Brabant wallon ainsi que certaines institutions de la province de Hainaut.
Créée sous la forme d’un groupe informel de travail réunissant essentiellement des hôpitaux bruxellois depuis 1998, la plate-forme régionale d’hygiène hospitalière Bruxelles-Brabant wallon fédère, depuis l’automne 2002, les 35 médecins et les 47 infirmiers hygiénistes de 56 hôpitaux de la région bruxelloise, du Brabant wallon ainsi que certaines institutions de la province de Hainaut.

Antwoord: 1 Grouping voor 1 MA: 1 module 1 met o.a. 1 cover letter + 1 gemeenschappelijk application form voor de hele groep (met duidelijke opsomming van de individuele variaties in de groep: nummer uit de guideline + korte omschrijving voor elke individuele variatie) + één Module 2,3,4, of 5 (naargelang wat van toepassing is) waarin alle aangevraagde wijzigingen zijn opgenomen.
Réponse : 1 Grouping pour 1 MA : 1 module 1 avec e.a. 1 cover letter + 1 application form commun à l’ensemble du groupe (avec une énumération claire des variations individuelles dans le groupe : numéro provenant de la guideline + brève description pour chaque variation individuelle) + un Module 2, 3, 4, ou 5 (en fonction de ce qui s’applique) reprenant toutes les modifications demandées.

Vraag 2. 3 Welke nummering dient in het application form aangegeven te worden voor Nationale groepen van variaties?
Question 2. 3 Quelle numérotation doit être indiquée dans l’application form pour des grouping nationaux de variations ?

De implementatiedatum dient vermeld te worden in de application form.
Maximum 1 an avant l’introduction des autres variations IA. La date d’implémentation doit être indiquée dans l’application form.

Het application form dient duidelijk te vermelden dat het om een volledige update van module 3 gaat en de wijzigingen dienen er duidelijk in aangegeven te zijn.
L’application form doit mentionner clairement qu’il s’agit d’une mise à jour complète du module 3 et les modifications doivent y être indiquées clairement.

De inhoud van het dossier bestaat uit een cover letter, application form (beschikbaar op [http ...]
Le contenu du dossier consiste en une cover letter, un application form (disponible sur [http ...]