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U.S. Department of Health and Human Services

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Reteplase Product Approval Information - Licensing Action

Proper name: Reteplase
Tradename: Retavase
Manufacturer: Boehringer Mannheim GmbH, Werk Penzberg, Federal Republic of Germany, License #1211
Indication for Use: In the management of acute myocardial infarction (AMI) in adults for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure and the reduction of mortality associated with AMI
Approval Date: 10/30/96
Type of submission: Biologics license application

 


Approval Letter (PDF)

Reviews
      Clinical Review (PDF)
      Pharmacokinetics Review (PDF)
      Pharmacologist's Review (PDF)
      Product Review (PDF)