Ecokinase

Withdrawn

This medicine's authorisation has been withdrawn

reteplase

Overview

On 29 August 1996, the European Commission issued a Marketing Authorisation valid throughout the European Union for the medicinal product Ecokinase, which contains reteplase. The pharmaceutical company responsible for this medicinal product was Galenus Mannheim.

On 28 January 1999, the Marketing Authorisation holder notified the European Commission about their decision to withdraw the Marketing Authorisation for Ecokinase.

On 30 July 1999, the European Commission adopted the decision withdrawing the Marketing Authorisation for this medicinal product for human use “ECOKINASE – Reteplase” EU/1/96/017/001. Pursuant to this decision the European Public Assessment Report for Reteplase has been removed from the EMA website.

For information, it should be noted that there is still a Marketing Authorisation valid throughout the European Union for another product Rapilysin, which contains reteplase. The pharmaceutical company responsible for this medicinal product is Roche Registration Ltd., UK.

Product information

Product details

• Name of medicine:
  Ecokinase
• Active substance:
  reteplase
• International non-proprietary name (INN) or common name:
  reteplase
• Therapeutic area (MeSH):
  Myocardial Infarction
• Anatomical therapeutic chemical (ATC) code:
  B01AD07

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Thrombolytic therapy of acute myocardial infarction

Authorisation details

• EMA product number:
  EMEA/H/C/000106
• Marketing authorisation holder:
  Roche Registration Ltd.

  6 Falcon Way; Shire Park; Welwyn Garden City AL7 1TW; United Kingdom

• Marketing authorisation issued:
  29/08/1996
• Withdrawal of marketing authorisation:
  30/07/1999