Traduction de «product labeling and risk » (Néerlandais → Français) :

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.

A European regulation that has entered into force on 1 July 2004 stipulates that, in order to inform the consumer of possible health risks, the labelling of beverages that contain caffeine in a proportion in excess of 150 mg/l should contain the mention “high caffeine content” followed by the caffeine content expressed in mg/100 ml in the same field of vision as the name under which the product is sold (Directive 2002/67/EC).
Enfin, une réglementation européenne, entrée en vigueur au 1er juillet 2004, stipule que l’étiquetage de boissons contenant plus de 150 mg de caféine par litre doit comporter la mention « teneur élevée en caféine » et la mention de sa quantité (en mg/100 ml) dans le même champ de vision du produit afin d’avertir le consommateur des risques possibles pour la santé (Directive 2002/67/CE).

Een welbepaald product opzoeken – in België of in een andere EU-lidstaat – kan via de “Green store”, een interactieve catalogus van producten die “de Bloem” dragen: www.eco-label.com (WEB)
Pour chercher un produit précis, en Belgique ou dans n’importe quel autre pays européen, consultez le « Green store », catalogue interactif des produits affichant « la Fleur » : www.eco-label.com (WEB)

Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory authorities in countries where regulatory applications for Prevenar 13 may be pending or may be submitted will approve such applications and their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.
This release contains forward-looking information that involves substantial risks and uncertainties regarding Prevenar 13, including its potential benefits; and the success of the AMC project for vaccines. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory authorities in countries where regulatory applications for Prevenar 13 may be pending or may be submitted will approve such applications and their decisions regarding labeling and other matters that could affect its availability or commercial potential; 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.

In het document van de Raad van Europa “Pathogen inactivation of labile Blood products” wordt het volgende besloten:” Pathogen inactivation of labile blood products will diminish the risk of transfusion-transmitted disease and immunomodulatory disturbances.
Dans le document du Conseil de l’Europe “Pathogen inactivation of labile Blood products”, la conclusion est la suivante : ” Pathogen inactivation of labile blood products will diminish the risk of transfusion-transmitted disease and immunomodulatory disturbances.

As for D-glucuronolactone, the group believes that this concerns a normal human metabolite deriving from glucose, which does not involve a structural risk with regard to mutagenicity or carcinogenicity. It also holds that both this component as well as its hydrolysis product, glucuronic acid, are endogenous metabolites in humans and other mammals, that they are naturally present in various food sources and that they are quickly metabolised into innocuous products and excreted.
Pour la D-glucuronolactone, le groupe considère qu’il s’agit d’un métabolite humain normal provenant du glucose qui ne présente pas de risque structural en termes de mutagénicité ou de carcinogénicité, que pour ce composant, comme pour son produit d’hydrolyse, l’acide glucuronique, il s’agit de métabolites endogènes chez l’homme et les autres mammifères, qu’ils se trouvent à l’état naturel dans diverses sources alimentaires et qu’ils sont rapidement métabolisés en produits sans danger et excrétés.

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3. REFERENTIES BfR Opinion No 041/2010 (2010) Health risks of nitric acid containing cleaning products.
3. REFERENCES BfR Opinion No 041/2010 (2010) Health risks of nitric acid containing cleaning products.

medicinal products with regard to vCJD risk», November 2003, EMEA/CPMP/BWP/5136/03. c) CHMP Position Statement «Creutzfeldt-Jakob disease and plasma-derived and urine-derived
Derived Medicinal Products with regard to vCJD risk», October 2004, EMEA/CPMP/BWP/5136/03.