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The marketing authorisation for Photobarr has been withdrawn at the request of the marketing authorisation holder.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

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

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 BG = bălgarski 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information ES = español 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information CS = čeština 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information DA = dansk 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information DE = Deutsch 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information ET = eesti keel 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information EL = elliniká 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information EN = English 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information FR = français 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information IT = italiano 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information LV = latviešu valoda 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information LT = lietuvių kalba 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information HU = magyar 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information MT = Malti 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information NL = Nederlands 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information PL = polski 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information PT = português 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information RO = română 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SK = slovenčina 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SL = slovenščina 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information FI = suomi 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information SV = svenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information IS = Islenska 21/04/2009 07/05/2012
PhotoBarr : EPAR - Product Information NO = Norsk 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 ES = español 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations CS = čeština 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations DA = dansk 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations DE = Deutsch 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations ET = eesti keel 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations EL = elliniká 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations EN = English 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations FR = français 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations IT = italiano 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations LV = latviešu valoda 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations LT = lietuvių kalba 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations HU = magyar 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations NL = Nederlands 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations PL = polski 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations PT = português 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SK = slovenčina 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations SL = slovenščina 25/11/2008 07/05/2012
PhotoBarr : EPAR - All Authorised presentations FI = suomi 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 BG = bălgarski 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV ES = español 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV CS = čeština 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV DA = dansk 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV DE = Deutsch 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV ET = eesti keel 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV EL = elliniká 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV EN = English 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV FR = français 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV IT = italiano 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV LV = latviešu valoda 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV LT = lietuvių kalba 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HU = magyar 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV MT = Malti 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV NL = Nederlands 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV PL = polski 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV PT = português 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV RO = română 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SK = slovenčina 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SL = slovenščina 21/04/2009 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV FI = suomi 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 (English only) 21/04/2009 07/05/2012

Initial marketing-authorisation documents

Name Language First published Last updated
PhotoBarr : EPAR - Scientific Discussion (English only) 25/11/2008 07/05/2012
PhotoBarr : EPAR - Procedural steps taken before authorisation (English only) 25/11/2008 07/05/2012

Withdrawn

This medicine is now withdrawn from use in the European Union

Related information

More information on Photobarr