Australia - English - Department of Health (Therapeutic Goods Administration)

omegapharm - mitomycin, quantity: 10 mg - injection, powder for - excipient ingredients: mannitol - mitomycin is indicated in the palliative treatment of carcinoma of the stomach, pancreas, colon, lung (non-small cell), breast, cervix, head and neck, liver and bladder.

Australia - English - Department of Health (Therapeutic Goods Administration)

omegapharm - mitomycin, quantity: 2 mg - injection, powder for - excipient ingredients: mannitol - mitomycin is indicated in the palliative treatment of carcinoma of the stomach, pancreas, colon, lung (non-small cell), breast, cervix, head and neck, liver and bladder.

United States - English - NLM (National Library of Medicine)

accord biopharma inc. - mitomycin (unii: 50sg953sk6) (mitomycin - unii:50sg953sk6) - mitomycin 40 mg in 80 ml - mutamycin ® (mitomycin) for injection is not recommended as single-agent, primary therapy. it has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. mitomycin is not recommended to replace appropriate surgery and/or radiotherapy. mitomycin is contraindicated in patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the past. mitomycin is contraindicated in patients with thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to other causes. insufficient data from clinical studies of mitomycin are available for patients 65 years of age and older to determine whether they respond differently than younger patients. postmarketing surveillance suggests that elderly patients may be more susceptible than younger patients to injection site reactions (see

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

kyowa kirin ltd - mitomycin - powder for intravesical solution - 40mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

kyowa kirin ltd - mitomycin - powder for solution for injection - 10mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

kyowa kirin ltd - mitomycin - powder for solution for injection - 20mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

kyowa kirin ltd - mitomycin - powder for solution for injection - 2mg

United States - English - NLM (National Library of Medicine)

mobius therapeutics llc - mitomycin (unii: 50sg953sk6) (mitomycin - unii:50sg953sk6) - mitomycin 0.2 mg in 1 ml - mitosol® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery. mitosol® is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past. based on findings in animals and mechanism of action [see clinical pharmacology (12.1)] , mitosol® can cause fetal harm when administered to a pregnant woman. there are no available data on mitosol® use in pregnant women to inform the drug-associated risk. in animal reproduction studies, parenteral administration of mitomycin resulted in teratogenicity (see data ). advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively. animal data parenteral administration of mitomycin in animal reproduction studies produced fetal malformat

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

accord-uk ltd - mitomycin - powder for solution for injection - 2mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

accord-uk ltd - mitomycin - powder for solution for injection - 10mg