Traduction de «approved clinical » (Néerlandais → Français) :

Q4 2008 Approved - Clinical trials underway to address FDA Complete Response letter (October 2009); resubmission planned by end 2010 Approved Q4 2009 Q1 2010 - FDA approval received after priority review
- Feed-back des autorités attendu au T4 2010 T4 2008 Autorisé - Essais cliniques en cours pour répondre à la « complete response letter » de la FDA (T4 2009), nouvelle demande prévue avant fin 2010 Autorisé T4 2009 T1 2010 - Autorisation de la FDA après revue prioritaire

R&D maintains momentum: Anti-cancer therapy Afinitor introduced in the US, awaiting EU approval; new biologic Ilaris and OTC brand Prevacid 24HR gain US approvals; clinical trials set to start in July for A(H1N1) pandemic flu vaccine
R&D maintient son élan: Afinitor, traitement anticancer lancé aux USA et en attente d’homologation dans l’Union européenne; Ilaris, nouveau médicament biologique, et Prevacid 24HR, vendu sans ordonnance, tous deux autorisés aux Etats-Unis; début en juillet des essais cliniques d’un vaccin contre la pandémie de grippe A(H1N1)

QAB149 COPD Q4 2008 Approved - Clinical trials underway to address FDA Complete Response letter (Q4 2009), resubmission planned for 2010
QAB149 BPCO T4 2008 Autorisé - Essais cliniques en cours pour répondre à la « complete response letter » de la FDA (T4 2009), nouvelle demande prévue en 2010

inspections ●● Monitoring the approved clinical trials by:
inspections ●● Monitoring the approved clinical trials by:

Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission
Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission

It is the R&D department’s role to protect the participants in clinical trials by giving scientific advice and evaluating, approving, monitoring and checking applications for clinical research, on the basis of sound scientific knowledge.
It is the R&D department’s role to protect the participants in clinical trials by giving scientific advice and evaluating, approving, monitoring and checking applications for clinical research, on the basis of sound scientific knowledge.

Oncology Gleevec/Glivec (USD 2.9 billion, +12% lc), a targeted therapy for some forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), has achieved sustained double-digit growth based on its leadership position in treating these cancers backed by new clinical data and regulatory approvals.
Oncologie Glivec/Gleevec (USD 2,9 milliards, +12% en m. l.), traitement ciblé contre certaines formes de leucémie myéloïde chronique (LMC) et de tumeurs stromales gastrointestinales (GIST), a enregistré une croissance soutenue à deux chiffres, grâce à sa position de leader dans le traitement de ces cancers, étayée par de nouveaux résultats cliniques et par des autorisations de mise sur le marché.

Valturna – a single-pill combination of Tekturna/Rasilez and Diovan (valsartan) – gained US regulatory approval in September based on clinical data showing this medicine offers significantly higher blood pressure reduction than either valsartan or aliskiren alone.
Valturna, un comprimé associant Rasilez/Tekturna et Diovan (valsartan), a obtenu, en septembre, son autorisation de mise sur le marché aux Etats-Unis. Cette décision s'est appuyée sur des données cliniques montrant que ce médicament provoque une baisse nettement plus importante de la pression sanguine que valsartan ou aliskiren seuls.

- Regulatory feedback expected in Q4 2010 Q4 2008 Approved Q3 2010 - Clinical trials to address US Food and Drug Administration (FDA) complete response letter (October 2009) completed in Q3 and data generated from these trials was submitted to the FDA in late September
2010 T4 2008 Autorisé T3 2010 - Essais cliniques pour répondre à la «complete response letter» de la FDA (oct. 2009) achevés au T3 et données soumises à fin septembre à la FDA

Vaccines and Diagnostics Menveo, a novel vaccine in clinical development to protect against four common types of meningococcal meningitis, is making good progress toward US and European regulatory approvals for initial use in adolescents (from age 11) and adults.
Vaccins et Diagnostic Menveo, un nouveau vaccin en développement clinique contre quatre types communs de méningite à méningocoques progresse vers l’obtention d’autorisations aux Etats-Unis et en Europe pour une première utilisation chez les adolescents (à partir de l’âge de 11) et les adultes.