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)

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

Page Last Updated: 05/16/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English