PhotoBarr
Withdrawn
This medicine's authorisation has been withdrawn
porfimer sodium
MedicineHumanWithdrawn
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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decision the European Public Assessment Report for PhotoBarr is updated to reflect that the marketing authorisation is no longer valid.
Product information
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).
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)
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