Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1 ANNEX ISUMMARY OF PRODUCT OF THE MEDICINAL PRODUCTSTELARA 130mg concentrate for solution for AND QUANTITATIVE COMPOSITIONEach vial contains 130mg ustekinumab in 26mL (5 mg/mL). ustekinumab is a fully human IgG1 monoclonal antibody to interleukin(IL)-12/23 produced in a murine myeloma cell line using recombinant DNA the full list of excipients, see FORMC oncentrate for solution for solution is clear, colourless to light indicationsCrohn s DiseaseSTELARA is indicated for the treatment of adult patients with moderately to severely active Crohn s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF antagonist or have medical contraindications to such colitisSTELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to.
2 1. NAME OF THE MEDICINAL PRODUCT STELARA 130mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 130mg ustekinumab in 26mL(5mg/mL).
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