Traduction de «regulatory decisions pending » (Néerlandais → Français) :

These include a historic five regulatory approvals to date in Japan for Rasilez, Tasigna, Xolair, Co-Dio and Lucentis, with regulatory decisions pending for Exforge and Galvus in the world’s second-largest pharmaceuticals market.
Celles-ci comprennent cinq autorisations de mise sur le marché au Japon, qui est le deuxième des plus importants marchés pharmaceutiques du monde, pour Rasilez, Tasigna, Xolair, Co-Dio et Lucentis, tandis que deux sont en suspens pour Exforge and Galvus.

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.

Decisions are pending on regulatory submissions in several countries, including Europe, Canada and Switzerland.
Des autorisations sont attendues dans plusieurs pays en Europe ainsi qu’au Canada et en Suisse.