Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - …
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - …
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal PRODUCT is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Bavencio 20 mg/mL concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 20 mg of avelumab. One vial of 10 mL contains 200 mg of avelumab. Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology. For the full list of excipients, see section 3.
confirmed Stevens–Johnson syndrome (SJS) or Toxic epidermal necrolysis (TEN) Permanently discontinue Other immune-related adverse reactions (including myositis, hypopituitarism, uveitis, myasthenia gravis, myasthenic syndrome, Guillain-Barré syndrome) For any of the following: • Grade 2 or Grade3 clinical signs or
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