Protopic Ointment (tacrolimus hydrate)
Protopik Ointment （tacrolimus hydrate）is an immunosuppressive agent used for atopic dermatitis.
Dosage forms are 0.1% ointment for adults and 0.03% ointment for children. Animal experiments on the new drug application showed an increased risk of carcinoma and malignant lymphoma. Some cases of malignant lymphoma and skin cancer were also reported in foreign countries.
In 2003 and 2004, we sent an open letter about the safety of the drug to the committee for drug approval in the Ministry of Health, Labour and Welfare, Japanese Dermatological Association, and Fujisawa Pharmaceutical Company.
Topics
- YAKUGAI Ombudsperson
- Tie-up Group
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