Vous avez cherché: authorisation (Danois - Grec)

post- authorisation
post- authorisation

name of the marketing authorisation holder
ΟΝΟΜΑ ΤΟΥ ΚΑΤΟΧΟΥ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ

advance authorisation scheme (aas) (forhåndstilladelsesordningen)
Καθεστώς προηγούμενης εξουσιοδότησης (advance authorisation scheme – «aas»)

notice to marketing authorisation holders – pharmacovigilance guidlines
notice to marketing authorisation holders – pharmacovigilance guidlines

the committee recommended that nexavar be given marketing authorisation.
Για ποιους λόγους εγκρίθηκε το nexavar; Η Επιτροπή Φαρμάκων για Ανθρώπινη Χρήση (chmp) έκρινε ότι τα οφέλη του nexavar υπερτερούν των κινδύνων που συνδέονται με αυτό για τη θεραπεία ασθενών με ηπατοκυτταρικό καρκίνωμα καθώς και ασθενών με προχωρημένο καρκίνωμα νεφρών οι οποίοι έχουν αποτύχει σε προηγούμενη θεραπεία με άλφα- ιντερφερόνη ή ιντερλευκίνη- 2 ή θεωρούνται ακατάλληλοι να λάβουν τέτοια θεραπεία.

european medicines agency post- authorisation evaluation of medicines for human use
european medicines agency post- authorisation evaluation of medicines for human use

excipients in the dossier for application for marketing authorisation for veterinary medicinal products
excipients in the dossier for application for marketing authorisation for veterinary medicinal products.

standard operating procedure on the release of assessment reports to applicants / marketing authorisation holders
ãéáí ðñï þ óï íì åãá åñç ä éá Ü í óô åðéóô ï éêÞ âÜ óç ô ãí ï ïÞóåù

the european agency for the evaluation of medicinal products pre- authorisation evaluation of medicines for human use
the european agency for the evaluation of medicinal products pre- authorisation evaluation of medicines for human use

pre- authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
pre- authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products

carcinogenicity testing pre- authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
carcinogenicity testing pre- authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products Κοινή οµάδα εργασίας cpmp/ cvmp για την ποιότητα

notice to marketing authorisation holders (for inclusion in volume 9 of the rules governing medicinal products for human use)
Κατευθυντήριες γραµµές notice to marketing authorisation holders (for inclusion in volume 9 of the rules governing medicinal products for human use)

position paper on the regulatory requirements for the authorisation of low- dose modified release asa formulations in the secondary prevention of cardiovascular events.
position paper on the regulatory requirements for the authorisation of low- dose modified release asa formulations in the secondary prevention of cardiovascular events.

contribution to part s. 2. 3 of the structure of the dossier for applications for marketing authorisation – control of starting materials for the production of plasma- derived medicinal products
contribution to part s. 2. 3 of the structure of the dossier for applications for marketing authorisation – control of starting materials for the production of plasma- derived medicinal products

concept paper on the development of an addendum on the clinical requirements of modified release medicinal products submitted as a line- extension of an existing marketing authorisation to the cpmp note for guidance on modified release oral and transdermal dosage forms: section ii (pharmacokinetic and clinical evaluation) (cpmp/ ewp/ 280/ 96)
concept paper on the development of an addendum on the clinical requirements of modified release medicinal products submitted as a line- extension of an existing marketing authorisation to the cpmp note for guidance on modified release oral and transdermal dosage forms: section ii (pharmacokinetic and clinical evaluation) (cpmp/ ewp/ 280/ 96)