PhotoBarr

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porfimer sodium

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Photobarr has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 07/05/2012

Authorisation details

Product details
Name
PhotoBarr
Agency product number
EMEA/H/C/000493
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
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Pinnacle Biologics B.V. 
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
25/03/2004
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

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

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.

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

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