PhotoBarr

porfimer sodium

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The marketing authorisation for Photobarr has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
PhotoBarr : EPAR - Summary for the public BG = bălgarski 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public ES = español 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public CS = čeština 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public DA = dansk 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public DE = Deutsch 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public ET = eesti keel 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public EL = elliniká 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public EN = English 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public FR = français 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public IT = italiano 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public LV = latviešu valoda 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public LT = lietuvių kalba 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public HU = magyar 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public MT = Malti 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public NL = Nederlands 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public PL = polski 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public PT = português 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public RO = română 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public SK = slovenčina 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public SL = slovenščina 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public FI = suomi 21/04/2009 07/05/2012
PhotoBarr : EPAR - Summary for the public SV = svenska 21/04/2009 07/05/2012

This EPAR was last updated on 07/05/2012 .

Authorisation details

Product details

Product details for PhotoBarr
NamePhotoBarr
Agency product numberEMEA/H/C/000493
Active substance

porfimer sodium

International non-proprietary name (INN) or common name

porfimer sodium

Therapeutic area Barrett Esophagus
Anatomical therapeutic chemical (ATC) code L01XD01

Publication details

Publication details for PhotoBarr
Marketing-authorisation holder

Pinnacle Biologics B.V.

Revision9
Date of issue of marketing authorisation valid throughout the European Union25/03/2004

Contact address:

Pinnacle Biologics B.V.
p/a Trust Company Amsterdam B.V.
Crystal Tower 21st Floor
Orlyplein 10
1043 DP Amsterdam
The Netherlands

Product information

Product information

20/04/2012  PhotoBarr -EMEA/H/C/000493 -T/0027

Name Language First published Last updated
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SV = svenska 25/11/2008 07/05/2012

Name Language First published Last updated
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 21/04/2009 07/05/2012

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Photodynamic therapy (PDT) with PhotoBarr is indicated for:

  • Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO)

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
PhotoBarr : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 21/04/2009 07/05/2012

Initial marketing-authorisation documents

Name Language First published Last updated
PhotoBarr : EPAR - Procedural steps taken before authorisation SV = svenska 25/11/2008 07/05/2012
PhotoBarr : EPAR - Scientific Discussion SV = svenska 25/11/2008 07/05/2012

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Photobarr