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Imciromab pentetate Product Approval Information - Licensing Action

Proper name: Imciromab pentetate
Tradename: Myoscint
Manufacturer: Centocor B.V., Leiden, The Netherlands, License #1178
Indication for Use: Preparation of Indium In 111 Imciromab pentetate to be used as a cardiac imaging agent for detecting the presence and/or identifying the location of myocardial injury in patients with suspected myocardial infarction
Approval Date: 7/3/96
Type of submission: Biologics license application

 


Summary Basis for Approval (PDF)

Labeling (PDF)