Traduction de «e-submission of renewal » (Néerlandais → Français) :

03.05.2007: omzendbrief 490 + aanvraagformulier VHB + Guidance on the e-submission of renewal of a national Marketing Authorisation, aan de houders van een vergunning voor het in de handel brengen van geneesmiddelen voor humaan gebruik.
03.05.2007 : circulaire 490 + formulaire de demande AMM + Guidance on the e-submission of renewal of a national Marketing Authorisation, aux titulaires d’une autorisation de mise sur le marché de médicaments à usage humain.

Selected pharmaceutical pipeline projects Project/ Potential indication/ Planned Current News update Compound Disease area submissions Phase ACZ885 Refractory gout acute 2010 III - On track for 2010 submission flares Systemic onset juvenile 2011 III idiopathic arthritis Type 2 diabetes II ≥2014 Secondary prevention of ≥2014 III - Phase III start planned end 2010 cardiovascular events Afinitor Neuroendocrine tumors 2010 III - On track for 2010 submission
Projets pharmaceutiques importants en pipeline Indication potentielle/ Projet / domaine Soumissions Phase Mises à jour molécule thérapeutique prévues actuelle ACZ885 Crises aiguës de la goutte réfractaire 2010 III - En voie d’être soumis en 2010

Submission for EU approval of a triple-medicine combination therapy for hypertension in a single pill containing Tekturna/Rasilez, amlodipine and hydrochlorothiazide was achieved in May, following the US submission in the first quarter.
l’hypertension en un comprimé unique associant Rasilez/Tekturna, amlodipine et hydrochlorothiazide, dans la foulée d’un dépôt similaire au premier trimestre aux Etats-Unis.

Selected pharmaceutical pipeline projects Project/ Potential indication/ Planned Current News update Compound Disease area submissions Phase ACZ885 Refractory gout acute flares 2010 III - On track for 2010 submission
Projets pharmaceutiques importants en pipeline Indication potentielle Projet / / domaine Soumissions Phase Mise à jour molécule thérapeutique prévues actuelle ACZ885 Crises aiguës de la goutte 2010 III - En voie d’être soumis en 2010 réfractaire

Working through the backlog - Vigilance 59 –– Five-yearly renewal (RQ) 59 –– EudraVigilance 59
Working through the backlog - Vigilance 59 –– Five-yearly renewal (RQ) 59 –– EudraVigilance 59

1. Renewal of a national marketing authorisation. 2 Periodic safety reports for medicines approved according to national, MRP, DCP and centralised procedures.
1. Renewal of a national marketing authorisation. 2 Periodic safety reports for medicines approved according to national, MRP, DCP and centralised procedures.

These variations will then be closed in groups with a request for clinical variation or a five-yearly renewal (RQ).
These variations will then be closed in groups with a request for clinical variation or a five-yearly renewal (RQ).

Processing of registrations, five-yearly renewals (RQ), variations for veterinary medicines via NP, DCP, MRP
Processing of registrations, five-yearly renewals (RQ), variations for veterinary medicines via NP, DCP, MRP

The renewal of the commission members’ mandates is in progress
The renewal of the commission members’ mandates is in progress

Applications for new opening (and renewed applications) that go back to 1981 are particularly problematic.
Applications for new opening (and renewed applications) that go back to 1981 are particularly problematic.