COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Claversal». (20A03440)
Estratto determina AAM/PPA n. 341/2020 del 19 giugno 2020 Autorizzazione del grouping di variazioni. E' autorizzato il seguente grouping di variazioni: B.II.a.3.z), B.II.b.3.a), B.II.b.4.b), B.II.f.1.d), B.II.f.1.b.)1, B.II.b.5 z), B.II.d.1 z), B.II.d.1.c), B.II.d.1.c), B.II.d.1.c), B.II.d.1.g), B.II.d.2.d) modifica nella composizione degli eccipienti nel prodotto finito;
modifica minore nel procedimento di fabbricazione;
modifica del batch size del prodotto finito - sino a 10 volte inferiore (Aggiunta);
modifiche delle condizioni di stoccaggio del prodotto finito: conservare a una temperatura inferiore a 25°C;
estensione della shelf-life del prodotto finito CLAVERSAL 500 mg compresse rivestite (A.I.C. 027308016) da ventiquattro mesi a trentasei mesi;
modifica minore dei limiti applicati durante la fabbricazione del prodotto finito (Tableting step). modifica del limite «Aspetto»;
modifica minore dei limiti di specifica del prodotto finito. modifica del limite «Aspetto»;
aggiunta di nuovi parametri di specifica alla specifica con i corrispondenti metodi di prova;
sostituzione di un parametro di specifica con il corrispondente metodo di prova;
sostituzione della procedura di prova del prodotto finito. A seguito delle modifiche richieste, vengono modificati i paragrafi 6.3 e 6.4 del riassunto delle caratteristiche...
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.