Vertaling van "has been completed and a regulatory submission remains " (Nederlands → Frans) :

MenB, in development as a vaccine to protect against the B serogroup of meningococcal meningitis, is in Phase III studies in Europe, where patient enrollment has been completed and a regulatory submission remains on track for 2010.
MenB, en développement en tant que vaccin pour protéger contre le sérogroupe B de la méningite à méningocoque, et en études de phase II en Europe.

Regulatory submissions have also been completed in Japan and China.
Des demandes d’autorisation ont été également déposées au Japon et en Chine.

Menveo, which was submitted in 2008 for US regulatory approval as a new vaccine to protect against four common types of meningococcal meningitis in people age 11-55, has received a Complete Response letter from the FDA requesting additional information on the submission’s clinical and CMC (Chemistry Manufacturing and Control) sections.
Menveo, a été soumis en 2008 aux autorités sanitaires américaines en vue d’obtenir son autorisation en tant que vaccin contre quatre types communs de méningite à méningocoques chez les personnes âgées de 11 à 55 ans. Ce médicament a reçu de la FDA une «Complete Response letter» demandant des informations complémentaires sur les sections Clinique et CMC (Chemistry Manufacturing and Control) du dossier.

The aim has been to ensure the FAMHP’s continued ability to remain at the forefront of European countries for those aspects for which electronic submission becomes obligatory from 2009.
The aim has been to ensure the FAMHP’s continued ability to remain at the forefront of European countries for those aspects for which electronic submission becomes obligatory from 2009.