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Direct Healthcare Professional Communication (DHPC) on Mitem® 20 mg: Restrictions of use for intravenous administration

Active substance: mitomycine

The company Substipharm informs that the medicinal product Mitem® 20 mg (mitomycine) - powder for the preparation of a solution for injection or infusion or powder and solvent for the preparation of a solution for intravesical use - may no longer be used for intravenous administration until further notice. The restriction of use is in the interest of patient safety due to a possible drug risk during intravenous administration.

Update: Information Letter on Mitem 20 mg, 22.03.2023

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 125KB, File does not meet accessibility standards