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Abciximab
Product Approval Information - Licensing Action
Proper name: Abciximab
Tradename: ReoPro
Manufacturer: Centocor B.V., Leiden, The Netherlands, License #1178
Indication for Use: Expanded indication to provide for revised dosage and patient management guidelines to reduce bleeding, and to include additional information on readministration. Indication now includes treatment of a broad range of patients undergoing percutaneous coronary intervention and patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours
Approval Date: 11/5/97
Type of submission: Biologics license supplement
Approval Letter (PDF),
(Text)
Supervisory Overview 1 (PDF)
Supervisory Overview 2 (PDF)
Labeling (PDF)
Medical Officers Review (PDF)
Clinical Review (PDF)
Last Updated: 3/5/2001
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Date created: September 16, 2003 |
