PhotoBarr
Withdrawn
This medicine's authorisation has been withdrawn
porfimer sodium
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Photobarr has been withdrawn at the request of the marketing authorisation holder.
PhotoBarr : EPAR - Summary for the public
English (EN) (509.22 KB - PDF)
First published: Last updated:
български (BG) (446.07 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
español (ES) (349.12 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
čeština (CS) (409.41 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
dansk (DA) (349.11 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Deutsch (DE) (351.05 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
eesti keel (ET) (362.9 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
ελληνικά (EL) (778.07 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
français (FR) (350.61 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
italiano (IT) (349.64 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
latviešu valoda (LV) (416.02 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
lietuvių kalba (LT) (378.39 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
magyar (HU) (400.91 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Malti (MT) (440.36 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Nederlands (NL) (346.54 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
polski (PL) (409.39 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
português (PT) (347.66 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
română (RO) (379.9 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
slovenčina (SK) (405.55 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
slovenščina (SL) (401.33 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Suomi (FI) (348.91 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
svenska (SV) (362.29 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Product information
PhotoBarr : EPAR - Product Information
English (EN) (1.12 MB - PDF)
First published: Last updated:
български (BG) (1.51 MB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
español (ES) (761.23 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
čeština (CS) (1.32 MB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
dansk (DA) (665.92 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Deutsch (DE) (818.55 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
eesti keel (ET) (679.01 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
ελληνικά (EL) (3.45 MB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
français (FR) (743.86 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
íslenska (IS) (1.12 MB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
italiano (IT) (725.89 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
latviešu valoda (LV) (1.49 MB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
lietuvių kalba (LT) (847.91 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
magyar (HU) (1.32 MB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Malti (MT) (1.39 MB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Nederlands (NL) (722.02 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
norsk (NO) (1.1 MB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
polski (PL) (1.46 MB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
português (PT) (745.16 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
română (RO) (929.66 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
slovenčina (SK) (1.25 MB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
slovenščina (SL) (1.2 MB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Suomi (FI) (675.92 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
svenska (SV) (667.04 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Latest procedure affecting product information:
T/0027
20/04/2012
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)
First published: Last updated:
español (ES) (227.88 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
čeština (CS) (300.5 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
dansk (DA) (227.86 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
Deutsch (DE) (227.91 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
eesti keel (ET) (269.44 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
ελληνικά (EL) (301.42 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
français (FR) (227.85 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
italiano (IT) (227.42 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
latviešu valoda (LV) (302.67 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
lietuvių kalba (LT) (291.78 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
magyar (HU) (290.79 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
Nederlands (NL) (228.12 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
polski (PL) (304.7 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
português (PT) (227.92 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
slovenčina (SK) (301.35 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
slovenščina (SL) (290.42 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
Suomi (FI) (228.16 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
svenska (SV) (227.88 KB - PDF)
First published: 25/11/2008Last updated: 07/05/2012
PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
English (EN) (471.02 KB - PDF)
First published: Last updated:
български (BG) (401.8 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
español (ES) (257.08 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
čeština (CS) (383.62 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
dansk (DA) (257.99 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Deutsch (DE) (257.86 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
eesti keel (ET) (257.3 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
ελληνικά (EL) (698.87 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
français (FR) (258.49 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
italiano (IT) (257.53 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
latviešu valoda (LV) (391.62 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
lietuvių kalba (LT) (335.14 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
magyar (HU) (355.07 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Malti (MT) (426.52 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Nederlands (NL) (258.49 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
polski (PL) (367.46 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
português (PT) (259.14 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
română (RO) (334.53 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
slovenčina (SK) (446.1 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
slovenščina (SL) (371.02 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
Suomi (FI) (256.03 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
svenska (SV) (257.5 KB - PDF)
First published: 21/04/2009Last updated: 07/05/2012
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 agentsTherapeutic 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
- Revision
- 9
Assessment history
PhotoBarr : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (327.48 KB - PDF)
First published: Last updated:
More information on Photobarr
Public statement on Photobarr: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/284281/2012
English (EN) (43.08 KB - PDF)
First published: Last updated:
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.
This page was last updated on