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 Branded drug
A pharmaceutical product which distinctly differs from previously approved drugs in its effective ingredients along with quantity, directions for use, dosage, efficacy, form, etc., and has been approved by the government for manufacture and sale. Additionally, in the case of Japan, such products are required to undergo re-examination by the Minister of Health, Labour and Welfare (as stipulated in Article 14, Clause 4, Item 1 of the Pharmaceutical Law).


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