COMUNICATO - Comunicato di rettifica relativo all'estratto della determina V&A n. 915/2015 del 14 maggio 2015, recante: «Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano 'Bicalutamide Ratiopharm'». (15A04945)
Il testo dell'estratto della determina indicata in oggetto, pubblicato nella Gazzetta Ufficiale - serie generale n. 134 - del 12 giugno 2015, deve intendersi annullato ed integralmente sostituito dal seguente: «E' autorizzato il seguente Grouping di variazioni: Modifica della composizione del prodotto finito (eccipienti). Modifica di impressioni, rilievi o altre marcature. Modifica del sistema di colorazione del prodotto finito. Modifica del peso dello strato di copertura. Modifica del processo di produzione del prodotto finito. Aggiunta di nuove dimensioni del lotto. Modifica delle prove in corso di fabbricazione (durezza). Sostituzione della specifica identificazione con relativo metodo (al rilascio). Modifica dei limiti di specifica per la dissoluzione. Modifica della specifica impurezze e del relativo metodo al rilascio ed al termine del periodo di validita'. Modifica della frequenza dei test microbiologici e dell'identificazione dell'ossido di titanio al rilascio ed al termine del periodo di validita'. Sostituzione dei metodi analitici per l'identificazione dell'ossido di titanio e il titolo del principio attivo. Sostituzione del materiale di confezionamento primario da PVC/PE/PvDC/Al a transparent PVC/PVdC/Al blisters. Introduzione della condizione di conservazione: Tenere il blister nel confezionamento esterno per proteggerlo dalla luce. Riduzione del periodo di validita' del prodotto finito da 5 a 3 anni. Modifica dei siti di produzione del prodotto finito. Rafforzamento dei limiti applicati in corso di fabbricazione (umidita' del granulato). Aggiunta di due nuove prove in corso di fabbricazione: peso individuale (non rivestite e rivestite), spessore...
Per continuare a leggere
RICHIEDI UNA PROVAGli abbonati possono accedere alla versione segnalata di questo caso.
You can sign up for a trial and make the most of our service including these benefits.
Perché iscriversi a vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Gli abbonati possono vedere una lista di tutti i casi citati e la legislazione di un documento.
You can sign up for a trial and make the most of our service including these benefits.
Perché iscriversi a vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Gli abbonati possono vedere una lista di tutti i documenti che hanno citato il caso.
You can sign up for a trial and make the most of our service including these benefits.
Perché iscriversi a vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Gli abbonati possono vedere le versioni riviste della legislazione con emendamenti
You can sign up for a trial and make the most of our service including these benefits.
Perché iscriversi a vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Gli abbonati possono vedere tutte le eventuali correzioni effettuate sul caso.
You can sign up for a trial and make the most of our service including these benefits.
Perché iscriversi a vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Gli abbonati hanno accesso ad una rappresentazione grafica delle relazioni tra il caso corrente e i casi a lui collegati. Un'alternativa alla lista dei casi, la 'Mappa dei Precedenti', rende più facile stabilire quale caso ha maggiore rilevanza nella tua ricerca e permette di capire quali casi meritano un ulteriore approfondimento. La visione d'insieme permette inoltre di capire come il caso è stato ricevuto
Perché iscriversi a vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Gli abbonati possono vedere la lista dei risultati collegati al tuo documento attraverso gli argomenti e le citazioni che Vincent ha trovato.
You can sign up for a trial and make the most of our service including these benefits.
Perché iscriversi a vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.