Revasc

RSS
Withdrawn

This medicine's authorisation has been withdrawn

desirudin
Medicine Human Withdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 9 July 1997, the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Revasc, which had been approved for prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement surgery. The marketing authorisation holder (MAH) responsible for Revasc was Canyon Pharmaceuticals Limited. 

On 18 July 2014, the European Commission issued a decision to withdraw the marketing authorisation for Revasc, following its receipt of a letter dated 19 June 2014 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for commercial reason. Revasc was not marketed in any European country. 

Pursuant to this decision, the European public assessment report for Revasc is updated to reflect that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information:IAIN/0031/G
23/01/2012
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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).

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dansk (DA) (181.15 KB - PDF)

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slovenščina (SL) (183.94 KB - PDF)

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Suomi (FI) (176.24 KB - PDF)

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svenska (SV) (181.18 KB - PDF)

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Product details

Name of medicine
Revasc
Active substance
desirudin
International non-proprietary name (INN) or common name
desirudin
Therapeutic area (MeSH)
Venous Thrombosis
Anatomical therapeutic chemical (ATC) code
B01AE01

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement surgery.

Authorisation details

EMA product number
EMEA/H/C/000104
Marketing authorisation holder
Canyon Pharmaceuticals Ltd.

Canyon Pharmaceuticals Limited
7th Floor
52-54 Gracechurch Street
London
EC3V 0EH
United Kingdom

Marketing authorisation issued
09/07/1997
Withdrawal of marketing authorisation
18/07/2014
Revision
12

Assessment history

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