PhotoBarr

Withdrawn

This medicine's authorisation has been withdrawn

porfimer sodium

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decision the European Public Assessment Report for PhotoBarr is updated to reflect that the marketing authorisation is no longer valid.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

Product information

PhotoBarr : EPAR - Product Information

PhotoBarr : EPAR - All Authorised presentations

PhotoBarr : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

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

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

PhotoBarr : EPAR - Procedural steps taken before authorisation

PhotoBarr : EPAR - Scientific Discussion