Revised EU monographs for heparin

July 19, 2008

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The MHRA have reported a revision of European Pharmacopoeia monographs for heparin.

“Following increased reports of adverse events associated with heparin preparations in the United States of America and some European countries, the European Pharmacopoeia monographs for Heparin Calcium (0332) and Heparin Sodium (0333) have undergone rapid revision and implementation in order to strengthen the level of testing required for quality control.

The revised monographs were adopted by the European Pharmacopoeia Commission on 25 June 2008 and are expected to come into effect on 1 August 2008, pending a decision by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH).

The revised monographs will be published in European Pharmacopoeia Supplement 6.4 and supersede the relevant monographs published in the British Pharmacopoeia 2008 and 2009 editions.

Further information and copies of the monographs can be obtained from the EDQM (European Directorate for Quality of Medicines & HealthCare) website“.