| Recommendations on biosimilar low-molecular-weight heparins. | |
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MedLine Citation:
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PMID: 19323788 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Based on the results of large clinical trials, several low-molecular-weight heparins (LMWHs) have been approved for prophylaxis and the treatment of venous and arterial thromboembolism. As a result of expiration or pending expiration of patent protection of the originator LMWHs, many generic or biosimilar LMWHs have been approved in some countries and more are likely to be approved elsewhere. Their greater availability may reduce the treatment costs. The Working Party on Requirements for Development of Biosimilar LMWHs of the Subcommittee on Control of Anticoagulation, Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis has reached a consensus on recommendations to ensure the quality of biosimilar LMWHs as compared with the originator LMWHs. |
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Authors:
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J Harenberg; A Kakkar; D Bergqvist; T Barrowcliffe; B Casu; J Fareed; P Mismetti; F A Ofosu; W Raake; M Samama; S Schulman; |
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Publication Detail:
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Type: Journal Article Date: 2009-03-23 |
Journal Detail:
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Title: Journal of thrombosis and haemostasis : JTH Volume: 7 ISSN: 1538-7836 ISO Abbreviation: J. Thromb. Haemost. Publication Date: 2009 Jul |
Date Detail:
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Created Date: 2009-07-06 Completed Date: 2009-10-22 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101170508 Medline TA: J Thromb Haemost Country: England |
Other Details:
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Languages: eng Pagination: 1222-5 Citation Subset: IM |
Affiliation:
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Clinical Pharmacology, Faculty of Medicine Mannheim, Ruprecht-Karls University Heidelberg, Mannheim, Germany. job.harenberg@medma.uni-heidelberg.de |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Guidelines as Topic* Heparin, Low-Molecular-Weight / chemistry, pharmacokinetics, pharmacology, therapeutic use* Humans Kidney Diseases / metabolism Thromboembolism / prevention & control* |
| Chemical | |
Reg. No./Substance:
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0/Heparin, Low-Molecular-Weight |
| Comments/Corrections | |
Comment In:
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J Thromb Haemost. 2009 Jul;7(7):1218-21
[PMID:
19422450
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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