COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Dutas». (16A01786)
Estratto determina n. 259/2016 del 22 febbraio 2016 Medicinale: DUTAS. Titolare A.I.C.: Pharmacare srl - Via Marghera, 29 - 20149 - Milano, Italia. Confezione: «0,5 mg capsule molli» 10 capsule in blister PVC/PVDC/AL - A.I.C. n. 043912017 (in base 10) 19W2UK (in base 32). Confezione: «0,5 mg capsule molli» 30 capsule in blister PVC/PVDC/AL - A.I.C. n. 043912029 (in base 10) 19W2UX (in base 32). Confezione: «0,5 mg capsule molli» 50 capsule in blister PVC/PVDC/AL - A.I.C. n. 043912031 (in base 10) 19W2UZ (in base 32). Confezione: «0,5 mg capsule molli» 60 capsule in blister PVC/PVDC/AL - A.I.C. n. 043912043 (in base 10) 19W2VC (in base 32). Confezione: «0,5 mg capsule molli» 90 capsule in blister PVC/PVDC/AL - A.I.C. n. 043912056 (in base 10) 19W2VS (in base 32). Forma farmaceutica: Capsule molli. Composizione: ogni capsula contiene: principio attivo: 0,5 mg di dutasteride;
eccipienti: contenuto delle capsule: Butilidrossitoluene (E321);
Glicerolo mono caprilcaprato (tipo I);
Involucro della capsula: gelatina;
glicerolo;
titanio diossido (E171);
ossido di ferro giallo (E172);
altri eccipienti: trigliceridi a catena media;
lecitina (puo' contenere olio di soia) (E322);
acqua demineralizzata. Produttore/i del principio attivo (con eventuale indicazioni delle fasi di produzione): dott. Reddy's Laboratories Limited, Chemical Technical Operations-II Plot No110&111, Sri Venkateswara Co-operative Industrial Estate Bollaram, Jinnaram, Medak District 502 325 Andhra Pradesh, India. Produzione: Cyndea Pharma, S.L - Poligono Industrial Emiliano Revilla Sanz, Avenida de Agreda, 31 Olvega, 42110, Soria - Spagna;
Cipla Limited, D7 MIDC Industrial Area, Kurkumbh, IN-413 802 Dist. Pune, Maharashtra, India;
Alcala Farma S.L., Ctra. M-300, Km. 29,920, Alcala' de Henares, 28802 (Madrid) Spagna. Confezionamento primario e secondario: Cyndea Pharma, S.L Poligono Industrial Emiliano Revilla Sanz, Avenida de Agreda, 31 Olvega, 42110, Soria - Spagna;
Alcala Farma S.L., Ctra. M-300, Km. 29,920, Alcala' de Henares, 28802 (Madrid) Spagna;
Cipla Limited, D7 MIDC Industrial Area, Kurkumbh, IN-413 802 Dist. Pune, Maharashtra, India. Controllo dei lotti: Cyndea Pharma, S.L, Poligono Industrial Emiliano Revilla Sanz, Avenida de Agreda, 31 Olvega, 42110, Soria;
Alcala Farma S.L., Ctra. M-300, Km. 29,920, Alcala' de Henares, 28802 (Madrid) Spagna;
Sabater Pharma SA, C/Jose' Argemi', 13-15 Esplugues de Llobregat, 08950 Barcellona, Spagna;
Galenicum Health S.L., Avda. Cornella...
Per continuare a leggere
RICHIEDI UNA PROVABuone notizie, abbiamo trovato un account attivo con questa email!
Puoi accedere qui.
Hai dimenticato la tua password?
Clicca qui per resettare la tua password.
A verification link has been sent to your email account!
Please click on the link that has been sent to your email account to verify your email and continue the registration process.
We have found that your academic organisation currently subscribes to vLex.
To receive access to vLex:
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
We have found that your organisation currently subscribes to vlex.
To receive access to vLex:
- Use the following link to sign up from your portal.
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
OR
You can signup for an individual account here.
Gli 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.
Ci sono molte altre ragioni per abbonarsi.
-
Global Coverage
Access over 120 million legal information documents, including the largest collection of common law and civil law content on one intuitive and advanced service.
-
Updated with over 20,000 cases each month
Each month thousands of new cases and legal documents are added to vLex Justis, providing you with up-to-date content and a wider range of information to support your research.
-
AI-powered research
Are you confident your research is complete? Use our AI-powered tool, Vincent, to conduct truly comprehensive research, based on in-document search and analysis.
-
Know where to start your research
The only service to feature exclusive, comprehensive and up-to-date legal information from 130 jurisdictions. This includes the largest collections of common and civil law judgments, exclusive law reports, legislation, regulations, dockets, books, journals and international news.
Buone notizie, abbiamo trovato un account attivo con questa email!
Puoi accedere qui.
Hai dimenticato la tua password?
Clicca qui per resettare la tua password.
A verification link has been sent to your email account!
Please click on the link that has been sent to your email account to verify your email and continue the registration process.
We have found that your academic organisation currently subscribes to vLex.
To receive access to vLex:
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
We have found that your organisation currently subscribes to vlex.
To receive access to vLex:
- Use the following link to sign up from your portal.
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
OR
You can signup for an individual account here.
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.
Ci sono molte altre ragioni per abbonarsi.
-
Global Coverage
Access over 120 million legal information documents, including the largest collection of common law and civil law content on one intuitive and advanced service.
-
Updated with over 20,000 cases each month
Each month thousands of new cases and legal documents are added to vLex Justis, providing you with up-to-date content and a wider range of information to support your research.
-
AI-powered research
Are you confident your research is complete? Use our AI-powered tool, Vincent, to conduct truly comprehensive research, based on in-document search and analysis.
-
Know where to start your research
The only service to feature exclusive, comprehensive and up-to-date legal information from 130 jurisdictions. This includes the largest collections of common and civil law judgments, exclusive law reports, legislation, regulations, dockets, books, journals and international news.
Buone notizie, abbiamo trovato un account attivo con questa email!
Puoi accedere qui.
Hai dimenticato la tua password?
Clicca qui per resettare la tua password.
A verification link has been sent to your email account!
Please click on the link that has been sent to your email account to verify your email and continue the registration process.
We have found that your academic organisation currently subscribes to vLex.
To receive access to vLex:
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
We have found that your organisation currently subscribes to vlex.
To receive access to vLex:
- Use the following link to sign up from your portal.
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
OR
You can signup for an individual account here.
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.
Ci sono molte altre ragioni per abbonarsi.
-
Global Coverage
Access over 120 million legal information documents, including the largest collection of common law and civil law content on one intuitive and advanced service.
-
Updated with over 20,000 cases each month
Each month thousands of new cases and legal documents are added to vLex Justis, providing you with up-to-date content and a wider range of information to support your research.
-
AI-powered research
Are you confident your research is complete? Use our AI-powered tool, Vincent, to conduct truly comprehensive research, based on in-document search and analysis.
-
Know where to start your research
The only service to feature exclusive, comprehensive and up-to-date legal information from 130 jurisdictions. This includes the largest collections of common and civil law judgments, exclusive law reports, legislation, regulations, dockets, books, journals and international news.
Buone notizie, abbiamo trovato un account attivo con questa email!
Puoi accedere qui.
Hai dimenticato la tua password?
Clicca qui per resettare la tua password.
A verification link has been sent to your email account!
Please click on the link that has been sent to your email account to verify your email and continue the registration process.
We have found that your academic organisation currently subscribes to vLex.
To receive access to vLex:
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
We have found that your organisation currently subscribes to vlex.
To receive access to vLex:
- Use the following link to sign up from your portal.
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
OR
You can signup for an individual account here.
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.
Ci sono molte altre ragioni per abbonarsi.
-
Global Coverage
Access over 120 million legal information documents, including the largest collection of common law and civil law content on one intuitive and advanced service.
-
Updated with over 20,000 cases each month
Each month thousands of new cases and legal documents are added to vLex Justis, providing you with up-to-date content and a wider range of information to support your research.
-
AI-powered research
Are you confident your research is complete? Use our AI-powered tool, Vincent, to conduct truly comprehensive research, based on in-document search and analysis.
-
Know where to start your research
The only service to feature exclusive, comprehensive and up-to-date legal information from 130 jurisdictions. This includes the largest collections of common and civil law judgments, exclusive law reports, legislation, regulations, dockets, books, journals and international news.
Buone notizie, abbiamo trovato un account attivo con questa email!
Puoi accedere qui.
Hai dimenticato la tua password?
Clicca qui per resettare la tua password.
A verification link has been sent to your email account!
Please click on the link that has been sent to your email account to verify your email and continue the registration process.
We have found that your academic organisation currently subscribes to vLex.
To receive access to vLex:
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
We have found that your organisation currently subscribes to vlex.
To receive access to vLex:
- Use the following link to sign up from your portal.
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
OR
You can signup for an individual account here.
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

Ci sono molte altre ragioni per abbonarsi.
-
Global Coverage
Access over 120 million legal information documents, including the largest collection of common law and civil law content on one intuitive and advanced service.
-
Updated with over 20,000 cases each month
Each month thousands of new cases and legal documents are added to vLex Justis, providing you with up-to-date content and a wider range of information to support your research.
-
AI-powered research
Are you confident your research is complete? Use our AI-powered tool, Vincent, to conduct truly comprehensive research, based on in-document search and analysis.
-
Know where to start your research
The only service to feature exclusive, comprehensive and up-to-date legal information from 130 jurisdictions. This includes the largest collections of common and civil law judgments, exclusive law reports, legislation, regulations, dockets, books, journals and international news.
Buone notizie, abbiamo trovato un account attivo con questa email!
Puoi accedere qui.
Hai dimenticato la tua password?
Clicca qui per resettare la tua password.
A verification link has been sent to your email account!
Please click on the link that has been sent to your email account to verify your email and continue the registration process.
We have found that your academic organisation currently subscribes to vLex.
To receive access to vLex:
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
We have found that your organisation currently subscribes to vlex.
To receive access to vLex:
- Use the following link to sign up from your portal.
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
OR
You can signup for an individual account here.
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.
Ci sono molte altre ragioni per abbonarsi.
-
Global Coverage
Access over 120 million legal information documents, including the largest collection of common law and civil law content on one intuitive and advanced service.
-
Updated with over 20,000 cases each month
Each month thousands of new cases and legal documents are added to vLex Justis, providing you with up-to-date content and a wider range of information to support your research.
-
AI-powered research
Are you confident your research is complete? Use our AI-powered tool, Vincent, to conduct truly comprehensive research, based on in-document search and analysis.
-
Know where to start your research
The only service to feature exclusive, comprehensive and up-to-date legal information from 130 jurisdictions. This includes the largest collections of common and civil law judgments, exclusive law reports, legislation, regulations, dockets, books, journals and international news.
Buone notizie, abbiamo trovato un account attivo con questa email!
Puoi accedere qui.
Hai dimenticato la tua password?
Clicca qui per resettare la tua password.
A verification link has been sent to your email account!
Please click on the link that has been sent to your email account to verify your email and continue the registration process.
We have found that your academic organisation currently subscribes to vLex.
To receive access to vLex:
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
We have found that your organisation currently subscribes to vlex.
To receive access to vLex:
- Use the following link to sign up from your portal.
- Please contact your resource manager to setup an account.
- If you have an email address with the organisation, please use that.
OR
You can signup for an individual account here.