Document Detail


Differences of Present Recommendations and Guidelines for Generic Low-Molecular-Weight Heparins: Is There Room for Harmonization.
MedLine Citation:
PMID:  21406409     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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, the first generic LMWH enoxaparin has been approved by the Food and Drug Administration for clinical use in all medical indications. The European Medicines Agency has set up guidelines for the production of generic LMWHs. The International Society of Thrombosis, the North American Thrombosis Forum and other scientific organizations raised concerns regarding the safety of generic LMWHs due to economic reasons. These organizations have published statements for the production of generic LMWHs to ensure the quality of the products and the safety for patients. Ideally, the differences between the actual recommendations and guidelines for the production of generic version of LMWHs should be harmonized.
Authors:
Job Harenberg
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-3-14
Journal Detail:
Title:  Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis     Volume:  -     ISSN:  1938-2723     ISO Abbreviation:  -     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-3-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9508125     Medline TA:  Clin Appl Thromb Hemost     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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