PhotoBarr

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Withdrawn

This medicine's authorisation has been withdrawn

porfimer sodium
MedicineHumanWithdrawn

Romanian is available via eTranslation, the European Commission's machine translation service.

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 25 March 2004 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product PhotoBarr (porfimer sodium) for Photodynamic therapy (PDT) for ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO). The marketing authorisation holder (MAH) responsible for PhotoBarr was Pinnacle. 

The European Commission was notified by a letter dated 29 November 2011 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for PhotoBarr for commercial reasons. PhotoBarr was only marketed in France. On 20 April 2012 the European Commission issued a decision to withdraw the marketing authorisation for PhotoBarr. 

Pursuant to this decision the European Public Assessment Report for PhotoBarr is updated to reflect that the marketing authorisation is no longer valid.

PhotoBarr : EPAR - Summary for the public

English (EN) (509.22 KB - PDF)

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български (BG) (446.07 KB - PDF)

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español (ES) (349.12 KB - PDF)

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čeština (CS) (409.41 KB - PDF)

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dansk (DA) (349.11 KB - PDF)

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Deutsch (DE) (351.05 KB - PDF)

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eesti (ET) (362.9 KB - PDF)

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ελληνικά (EL) (778.07 KB - PDF)

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français (FR) (350.61 KB - PDF)

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italiano (IT) (349.64 KB - PDF)

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latviešu (LV) (416.02 KB - PDF)

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lietuvių (LT) (378.39 KB - PDF)

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magyar (HU) (400.91 KB - PDF)

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Malti (MT) (440.36 KB - PDF)

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Nederlands (NL) (346.54 KB - PDF)

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polski (PL) (409.39 KB - PDF)

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português (PT) (347.66 KB - PDF)

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română (RO) (379.9 KB - PDF)

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slovenčina (SK) (405.55 KB - PDF)

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slovenščina (SL) (401.33 KB - PDF)

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suomi (FI) (348.91 KB - PDF)

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svenska (SV) (362.29 KB - PDF)

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Product information

PhotoBarr : EPAR - Product Information

English (EN) (1.12 MB - PDF)

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български (BG) (1.51 MB - PDF)

Prima publicare: 21/04/2009 Cea mai recent: 07/05/2012
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español (ES) (761.23 KB - PDF)

Prima publicare: 21/04/2009 Cea mai recent: 07/05/2012
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čeština (CS) (1.32 MB - PDF)

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dansk (DA) (665.92 KB - PDF)

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Deutsch (DE) (818.55 KB - PDF)

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eesti (ET) (679.01 KB - PDF)

Prima publicare: 21/04/2009 Cea mai recent: 07/05/2012
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ελληνικά (EL) (3.45 MB - PDF)

Prima publicare: 21/04/2009 Cea mai recent: 07/05/2012
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français (FR) (743.86 KB - PDF)

Prima publicare: 21/04/2009 Cea mai recent: 07/05/2012
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italiano (IT) (725.89 KB - PDF)

Prima publicare: 21/04/2009 Cea mai recent: 07/05/2012
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latviešu (LV) (1.49 MB - PDF)

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lietuvių (LT) (847.91 KB - PDF)

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magyar (HU) (1.32 MB - PDF)

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Malti (MT) (1.39 MB - PDF)

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Nederlands (NL) (722.02 KB - PDF)

Prima publicare: 21/04/2009 Cea mai recent: 07/05/2012
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polski (PL) (1.46 MB - PDF)

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português (PT) (745.16 KB - PDF)

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română (RO) (929.66 KB - PDF)

Prima publicare: 21/04/2009 Cea mai recent: 07/05/2012
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slovenčina (SK) (1.25 MB - PDF)

Prima publicare: 21/04/2009 Cea mai recent: 07/05/2012
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slovenščina (SL) (1.2 MB - PDF)

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suomi (FI) (675.92 KB - PDF)

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svenska (SV) (667.04 KB - PDF)

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Íslenska (IS) (1.12 MB - PDF)

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norsk (NO) (1.1 MB - PDF)

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Latest procedure affecting product information:T/0027
20/04/2012
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

PhotoBarr : EPAR - All Authorised presentations

English (EN) (482.71 KB - PDF)

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español (ES) (227.88 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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čeština (CS) (300.5 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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dansk (DA) (227.86 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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Deutsch (DE) (227.91 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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eesti (ET) (269.44 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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ελληνικά (EL) (301.42 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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français (FR) (227.85 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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italiano (IT) (227.42 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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latviešu (LV) (302.67 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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lietuvių (LT) (291.78 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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magyar (HU) (290.79 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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Nederlands (NL) (228.12 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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polski (PL) (304.7 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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português (PT) (227.92 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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slovenčina (SK) (301.35 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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slovenščina (SL) (290.42 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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suomi (FI) (228.16 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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svenska (SV) (227.88 KB - PDF)

Prima publicare: 25/11/2008 Cea mai recent: 07/05/2012
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PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

English (EN) (471.02 KB - PDF)

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български (BG) (401.8 KB - PDF)

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español (ES) (257.08 KB - PDF)

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čeština (CS) (383.62 KB - PDF)

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dansk (DA) (257.99 KB - PDF)

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Deutsch (DE) (257.86 KB - PDF)

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eesti (ET) (257.3 KB - PDF)

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ελληνικά (EL) (698.87 KB - PDF)

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français (FR) (258.49 KB - PDF)

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italiano (IT) (257.53 KB - PDF)

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latviešu (LV) (391.62 KB - PDF)

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lietuvių (LT) (335.14 KB - PDF)

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magyar (HU) (355.07 KB - PDF)

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Malti (MT) (426.52 KB - PDF)

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Nederlands (NL) (258.49 KB - PDF)

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polski (PL) (367.46 KB - PDF)

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português (PT) (259.14 KB - PDF)

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română (RO) (334.53 KB - PDF)

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slovenčina (SK) (446.1 KB - PDF)

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slovenščina (SL) (371.02 KB - PDF)

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suomi (FI) (256.03 KB - PDF)

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svenska (SV) (257.5 KB - PDF)

Prima publicare: 21/04/2009 Cea mai recent: 07/05/2012
Vizualizare

Product details

Name of medicine
PhotoBarr
Active substance
porfimer sodium
International non-proprietary name (INN) or common name
porfimer sodium
Therapeutic area (MeSH)
Barrett Esophagus
Anatomical therapeutic chemical (ATC) code
L01XD01

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)

Authorisation details

EMA product number
EMEA/H/C/000493
Marketing authorisation holder
Pinnacle Biologics B.V. 

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

Marketing authorisation issued
25/03/2004
Withdrawal of marketing authorisation
20/04/2012
Revision
9

Assessment history

PhotoBarr : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (327.48 KB - PDF)

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PhotoBarr : EPAR - Procedural steps taken before authorisation

English (EN) (520.24 KB - PDF)

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PhotoBarr : EPAR - Scientific Discussion

English (EN) (597.99 KB - PDF)

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More information on Photobarr

This product originally had an orphan designation granted on 6 March 2002. This designation was withdrawn from the Community register of orphan medicinal products in April 2013 upon request of the marketing authorisation holder.

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