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Journal article

Unlicensed and off-label uses of medicines: definitions and clarification of terminology

Abstract:

The terms 'licensed', 'unlicensed', and 'off-label', often used in relation to marketing and prescribing medicinal products, may confuse UK prescribers. To market a medicinal product in the UK requires a Marketing Authorization ('product licence') for specified indications under specified conditions, regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The Marketing Authorization includes the product's agreed terms of use (the 'label'), described in the Summary of Prod...

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Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1111/bcp.13394

Authors


More by this author
Institution:
University of Oxford
Division:
Medical Sciences Division
Department:
Primary Care Health Sciences
Oxford college:
Green Templeton; Green Templeton College
Role:
Author
ORCID:
0000-0003-1139-655X
More by this author
Role:
Author
ORCID:
0000-0003-3769-1346
Publisher:
Wiley Publisher's website
Journal:
British Journal of Clinical Pharmacology Journal website
Volume:
83
Issue:
12
Pages:
2615-2625
Publication date:
2017-09-26
Acceptance date:
2017-07-31
DOI:
EISSN:
1365-2125
ISSN:
0306-5251
Pubs id:
pubs:846608
URN:
uri:dbe3ec06-4c1b-4695-856f-07616c705591
UUID:
uuid:dbe3ec06-4c1b-4695-856f-07616c705591
Local pid:
pubs:846608

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