検索ワード: pharmacovigilance (ギリシア語 - イタリア語)

pharmacovigilance of veterinary medicinal products:
pharmacovigilance of veterinary medicinal products:

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

procedure for competent authorities on the undertaking of pharmacovigilance activities
procedure for competent authorities on the undertaking of pharmacovigilance activities

Κατευθυντήριες γραµµές revised rapid alert system in veterinary pharmacovigilance
linee guida revised rapid alert system in veterinary pharmacovigilance

note for guidance on the conduct of pharmacovigilance for centrally authorised products
note for guidance on the conduct of pharmacovigilance for centrally authorised products

procedure for competent authorities for pharmacovigilance information of veterinary medicinal products
procedure for competent authorities for pharmacovigilance information of veterinary medicinal products

note for guidance on the procedure for competent authorities on the undertaking of pharmacovigilance activities
note for guidance on the procedure for competent authorities on the undertaking of pharmacovigilance activities

conduct of pharmacovigilance for veterinary medicinal products authorised through the mutual recognition procedure
conduct of pharmacovigilance for veterinary medicinal products authorised through the mutual recognition procedure

electronic exchange of pharmacovigilance information for human and veterinary medicinal products in the european union
electronic exchange of pharmacovigilance information for human and veterinary medicinal products in the european union

rapid alert system (ras) and non- urgent information system (nuis) in human pharmacovigilance
rapid alert system (ras) and non-urgent information system (nuis) in human pharmacovigilance

Ο Κάτοχος Άδειας Κυκλοφορίας έχει δεσµευθεί να εφαρµόσει τις ενέργειες για τη Φαρµακοεπαγρύπνηση του προϊόντος, όπως αναφέρονται στο Σχέδιο Φαρµακοεπαγρύπνησης (pharmacovigilance plan).
il titolare dell’ autorizzazione all’ immissione in commercio si impegna ad effettuare le attività di farmacovigilanza dettagliate nel piano di farmacovigilanza.

prospective planning of pharmacovigilance notice to applicants – guideline on the summary of product characteristics (ec december 1999 – revised version)
prospective planning of pharmacovigilance notice to applicants – guideline on the summary of product characteristics (ec december 1999 – revised version)

Τίτλος εγγράφου revision of note for guidance on the conduct of pharmacovigilance for centrally authorised products revision of crisis management plan regarding centrally authorised products for human use guidance document for the implementation of the position paper on compliance with pharmacovigilance regulatory obligations contribution to note for guidance on the use of medicinal products during pregnancy:
titolo del documento revision of note for guidance on the conduct of pharmacovigilance for centrally authorised products revision of crisis management plan regarding centrally authorised products for human use guidance document for the implementation of the position paper on compliance with pharmacovigilance regulatory obligations contribution to note for guidance on the use of medicinal products during pregnancy:

Επιπλέον, ανανέωση του ΣΔΚ πρέπει να κατατίθεται: Όταν λαμβάνονται νέες πληροφορίες οι οποίες μπορεί να επηρέασουν το ισχύον Σχέδιο Φαρμακοεπαγρύπνυσης Προδιαγραφών Ασφαλείας (safety specification pharmacovigilance plan) ή της ενέργειες ελαχιστοποίησης του κινδύνου.
inoltre, deve essere presentato un rmp aggiornato: • quando dovesse essere ricevuta una qualsiasi informazione che possa avere impatto sulle attuali specifiche di sicurezza, sul piano di farmacovigilanza o sulle attività di minimizzazione del rischio