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・ Off-budget enterprise
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Off-licensed drug
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Off-licensed drug : ウィキペディア英語版
Off-licensed drug

In any country, an off-licensed drug does not have a licence for human use for any indication or age group in that country.
==Possible uses==
An unlicensed drug should only be used under certain circumstances:
*As part of a clinical trial.
*When it has been imported from a country where it does have a licence.
*When it has been prepared extemporaneously (e.g. a specialist dermatological mixed formulation for topical use or a mixture of a corticosteroid and local anaesthetic for injection into a joint).
*When it is prepared under a special licence (e.g. a liquid formulation for patients with difficulty in swallowing or a reduced-dose formulation for children).
*When the licence has been suspended, revoked, or not renewed, but the product is made available for named patients under specific circumstances (e.g. thalidomide is used for the treatment of multiple myeloma, leprosy, HIV infection).
*If the drug is not considered a medicine but is used to treat a rare condition (e.g. a rare metabolic disease).
*Most vitamins and vitamin supplements are sold in the uk without a product licence (P.L).

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
ウィキペディアで「Off-licensed drug」の詳細全文を読む



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