Overview on guidelines and recommendations for generic low-molecular-weight heparins

Thrombosis Research

Volumn 127, Issue SUPPL. 3, 2011, Pages

  Harenberg, Job ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

Generic low molecular weight heparin (LMWH); Guidelines for production; Prophylaxis; Venous and arterial thromboembolism

Indexed keywords

ENOXAPARIN; HEPARIN; LOW MOLECULAR WEIGHT HEPARIN;

ACUTE CORONARY SYNDROME; ANAPHYLAXIS; ARTERIAL THROMBOEMBOLISM; ARTICLE; BLEEDING; DEEP VEIN THROMBOSIS; DRUG EFFICACY; DRUG SAFETY; EXTRACORPOREAL CIRCULATION; FOOD AND DRUG ADMINISTRATION; HEMODIALYSIS; HEPARIN INDUCED THROMBOCYTOPENIA; HIP SURGERY; HUMAN; LIVER FUNCTION TEST; LUNG EMBOLISM; NONHUMAN; ORTHOPEDIC SURGERY; PERCUTANEOUS CORONARY INTERVENTION; PRACTICE GUIDELINE; PRIORITY JOURNAL; THROMBOCYTE COUNT; THROMBOEMBOLISM; VENOUS THROMBOEMBOLISM;

ANTICOAGULANTS; DRUGS, GENERIC; HEPARIN, LOW-MOLECULAR-WEIGHT; HUMANS; THROMBOEMBOLISM; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79251497005     PISSN: 00493848     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0049-3848(11)70027-5     Document Type: Article

References (7)

1. FDA News Release, July 23, 2010 fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm220092.hm Accessed July 23, 2010.
2. FDA response to Citizen Petition Docket No. FDA-2003-P-0273.
3. EMEA. Guidelines on clinical and non-clinical development of medicinal products containing low-molecular-weight heparins. European Medical Agency. London, 19 March 2009. (EMEA/CHMP/BMWP/11826407enfin.pdf ). Accessed September 7, 2010.
4. J Harenberg, A Kakkar, D Bergqvist, T Barrowcliffe, B Casu, J Fareed on behalf of the Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis Recommendations on biosimilar low-molecular-weight heparins J Thromb Haemost 7 2009 1222 1225
5. E Kalodiki, J Fareed, WF Tapson, DA Hoppensteadt, CA Carter, I Sussman A consensus conference on complex biologies and low molecular weight heparin Int Angiol 29 2010 193 196
6. North American Thrombosis Forum Official Policy Statement regarding the protection of patient safety and patient rights on the matter of follow-on biologies natfonline.org/NATFbiologiesstatement.php Accessed September 7, 2010.
7. E Kalodiki, W Leon, SASAT and Task Force on Generic LMWHs SASAT (South Asian Society on Atherosclerosis and Thrombosis) proposal for regulatory guidelines for generic low molecular weight heparins (LMWHs) Clin Appl Thromb Hemost 15 2009 8 11