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Nofetumomab
Product Approval Information - Licensing Action
Proper name: Nofetumomab
Tradename: Verluma
Manufacturer: Dr. Karl Thomae GmbH, 88397 Biberach/Riss, Germany, License #1199
Indication for Use: Detection of extensive stage disease in patients with biopsy-confirmed, previously untreated, small cell lung cancer
Approval Date: 8/20/96
Type of submission: Biologics license application
Approval Letter
(PDF),
(Text)
Label (PDF)
Reviews (PDF)
Clinical (40 pages)
Stability (2 pages)
Statistical (25 pages)
Last Updated: 3/5/2001
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Updated: September 25, 2003 |
