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U.S. Department of Health and Human Services

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Infliximab Product Information - Licensing Action

Proper name: Infliximab
Tradename: Remicade
Manufacturer: Centocor Inc, Malvern, PA, License #1242
Expanded Indication for Use: Inhibition of progression of structural damage in patients with rheumatoid arthritis who have had an inadequate response to methotrexate
Approval Date: 12/29/2000
Type of submission: Biologics license supplement

 


Approval Letter (PDF) 

Label (PDF)