PACCO PROCEDURA RADIOLOGIA

Informazioni principali

  • Nome commerciale:
  • PACCO PROCEDURA RADIOLOGIA
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Dispositivo medico

Documenti

  • per il pubblico:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per il pubblico.

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • PACCO PROCEDURA RADIOLOGIA
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • KIT CHIRURGICI (sono compresi solo i Kit certificati CE come tali)

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • N
  • Data dell'autorizzazione:
  • 13-11-2009
  • Ultimo aggiornamento:
  • 09-08-2016
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.

    Richiedi il foglio illustrativo per il pubblico.

16-7-2018

Determinazioni AIFA (16/07/2018)

Determinazioni AIFA (16/07/2018)

L'Agenzia Italiana del Farmaco rende disponibili un elenco di Determine riguardanti la classificazione ai sensi dell'art. 12 comma 5 legge 8 novembre 2012 n. 189 di medicinali per uso umano - approvati con procedura centralizzata.

Italia - AIFA - Agenzia Italiana del Farmaco

22-5-2018

Determinazioni AIFA (22/05/2018)

Determinazioni AIFA (22/05/2018)

L'Agenzia Italiana del Farmaco rende disponibili un elenco di Determine riguardanti la classificazione ai sensi dell'art. 12 comma 5 legge 8 novembre 2012 n. 189 di medicinali per uso umano - approvati con procedura centralizzata.

Italia - AIFA - Agenzia Italiana del Farmaco

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

21-9-2018

Regulatory and procedural guideline:  Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1, draft: consultation open

Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1, draft: consultation open

The guideline, which was developed to encourage optimal use and to minimise selection of antimicrobial resistance (AMR), was revised in order to improve consistency of the summary of product characteristics (SPCs) for antimicrobial products in the EU Member States.

Europe - EMA - European Medicines Agency

21-9-2018

Regulatory and procedural guideline:  Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

Regulatory and procedural guideline: Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

This report provides a final agreed draft Context of Use for public consultation describing where Stride Velocity measured at the ankle 95th Centile is deemed by CHMP as an appropriate endpoint in studies to support regulatory decision making on medicines for the treatment of Duchenne Muscular Dystrophy (DMD), together with CHMP’s scientific consideration of the submission leading to the draft opinion. The document also includes the questions posed by the applicant and also raised by CHMP to the Applic...

Europe - EMA - European Medicines Agency

26-7-2018

Regulatory and procedural guideline:  EudraVigilance registration manual

Regulatory and procedural guideline: EudraVigilance registration manual

Europe - EMA - European Medicines Agency

26-7-2018

Regulatory and procedural guideline:  EudraVigilance release notes v.1.17

Regulatory and procedural guideline: EudraVigilance release notes v.1.17

This document lists and briefly describes the following areas for the releases of EVWEB starting with the release on 22 November 2017.

Europe - EMA - European Medicines Agency

19-7-2018

Regulatory and procedural guideline:  Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms, adopted

Regulatory and procedural guideline: Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms, adopted

Critical Path Global Ltd.’s Critical Path for Parkinson’s (CPP) is a multinational consortium of the Critical Path Institute supported by Parkinson’s UK and industry. This broad collaboration of pharmaceutical companies, government agencies, academic institutions, and charities aims to accelerate the development of therapies for Parkinson’s disease (PD).

Europe - EMA - European Medicines Agency

19-7-2018

Regulatory and procedural guideline:  Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA).

Europe - EMA - European Medicines Agency

5-7-2018

Aggiornamento modelli delle variazioni tipo I rientranti nell'applicazione della Determina AIFA 25/08/2011 (05/07/2018)

Aggiornamento modelli delle variazioni tipo I rientranti nell'applicazione della Determina AIFA 25/08/2011 (05/07/2018)

Si porta all’attenzione di tutte le Aziende Farmaceutiche che, relativamente a medicinali autorizzati con procedura Nazionale o Mutuo Riconoscimento/Decentrata, l’Agenzia Italiana del Farmaco aggiorna i modelli per la pubblicazione in Gazzetta Ufficiale della Repubblica italiana delle variazioni rientranti nell’applicazione della Determina AIFA 25/08/2011 relativa alla procedura del silenzio/assenso.

Italia - AIFA - Agenzia Italiana del Farmaco

2-7-2018

Procedura operativa per le attività dei Responsabili Locali di Farmacovigilanza (RLFV) (02/07/2018)

Procedura operativa per le attività dei Responsabili Locali di Farmacovigilanza (RLFV) (02/07/2018)

A seguito dei cambiamenti introdotti con il simplified electronic reporting delle sospette reazioni avverse, si rende disponibile la nuova versione di procedura operativa per le attività dei Responsabili Locali di Farmacovigilanza (RLFV) aggiornata allo scopo di fornire indicazioni pratiche per facilitare l’inserimento in RNF delle informazioni riportate sulla scheda di sospetta reazione avversa (ADR).

Italia - AIFA - Agenzia Italiana del Farmaco

27-6-2018

Regulatory and procedural guideline:  Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product

Regulatory and procedural guideline: Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product

This document outlines the general principles to follow for the preparation of the summary of product characteristics (SmPC) for a generic, hybrid or biosimilar medicinal product to be authorised via the centralised procedure using a reference medicinal product authorised either at national level or centrally.

Europe - EMA - European Medicines Agency

19-6-2018

Regulatory and procedural guideline:  IRIS quick guide to registration

Regulatory and procedural guideline: IRIS quick guide to registration

Europe - EMA - European Medicines Agency

15-6-2018

Regulatory and procedural guideline:  EudraVigilance release notes v.1.15

Regulatory and procedural guideline: EudraVigilance release notes v.1.15

This document lists and briefly describes the following areas for the releases of EVWEB starting with the release on 22 November 2017.

Europe - EMA - European Medicines Agency

8-6-2018

Lista sostanze attive - generici (gennaio / maggio 2018)

Lista sostanze attive - generici (gennaio / maggio 2018)

L'Agenzia Italiana del Farmaco rende disponibile la lista delle sostanze attive per le quali è stata avviata la procedura di valutazione per il rilascio dell'AIC a seguito della validazione amministrativa della pratica.

Italia - AIFA - Agenzia Italiana del Farmaco

24-5-2018

Regulatory and procedural guideline:  EudraVigilance release notes v.1.14

Regulatory and procedural guideline: EudraVigilance release notes v.1.14

This document lists and briefly describes the following areas for the releases of EVWEB starting with the release on 22 November 2017.

Europe - EMA - European Medicines Agency

14-5-2018

Regulatory and procedural guideline:  EudraVigilance user manual for marketing authorisation holders

Regulatory and procedural guideline: EudraVigilance user manual for marketing authorisation holders

Marketing Authorisation Holders - EudraVigilance access via the EudraVigilance Data Analysis System

Europe - EMA - European Medicines Agency

3-5-2018

Regulatory and procedural guideline:  How to use the defective product report to notify a quality defect to European Medicines Agency

Regulatory and procedural guideline: How to use the defective product report to notify a quality defect to European Medicines Agency

How to use the defective product report to notify a quality defect to European Medicines Agency

Europe - EMA - European Medicines Agency

30-4-2018

Regulatory and procedural guideline:  Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances, draft: consultation open

Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances, draft: consultation open

The guideline, which was developed to encourage optimal use and to minimise selection of antimicrobial resistance (AMR), was revised in order to improve consistency of the summary of product characteristics (SPCs) for antimicrobial products in the EU Member States.

Europe - EMA - European Medicines Agency