Information Letter on Mitem 20 mg of the company Substipharm: Withdrawal of the restriction for intravenous administration
2023.03.22
Active substance: Mitomycin
Substipharm informs that the mitomycin-containing medicinal product Mitem® 20 mg - powder for the preparation of a solution for injection or infusion or powder and solvent for the preparation of a solution can be used again for intravenous administration. The restriction on use (see Information Letter September 2021) was imposed in the past in the interest of patient safety due to a potential risk from manufacturing-related specification deviations. The cause of the deviations has been resolved.