EU/3/01/059

About

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in August 2016 at the end of the period of market exclusivity.

On 19 September 2001, orphan designation (EU/3/01/059) was granted by the European Commission to TopoTarget A/S, Denmark, for dexrazoxane for the treatment of anthracycline extravasation.

The sponsorship was transferred to SpePharm Holding B.V., The Netherlands, in September 2010 and subsequently to Norgine B.V.,The Netherlands, in September 2013. In July 2014 the sponsorship was transferred to Clinigen Healthcare Ltd., United Kingdom.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
Dexrazoxane
Medicine name
Savene
Disease / condition
Treatment of anthracycline extravasations
Date of decision
19/09/2001
Outcome
Expired
Orphan decision number
EU/3/01/059

Review of designation

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in August 2016 at the end of the period of market exclusivity.

Sponsor's contact details

Clinigen Healthcare Ltd.
Pitcairn House
Crown Square
First Avenue
Burton-on-Trent
Staffordshire DE14 2WW
United Kingdom
Tel. +44 (0)7714 135 765
Fax +44 (0)1283 494 341
http://www.clinigengroup.com/patients

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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