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04 November 2011 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance protamine sulphate
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the CEP for the active substance protamine sulphate.
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04 November 2011 /Prices and reimbursement
Comments received on the reassessment of reimbursement status of strong analgesics (opioids)
The Danish Medicines Agency has received a number of comments for the Reimbursement Committee's discussion of reimbursement status of strong analgesics (opioids). These comments were presented to the Reimbursement Committee at its meeting on 27 September 2011. The Reimbursement Committee is currently processing a recommendation.
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02 November 2011 /Side effects and trials
Electronic reporting of SUSARs from other EU countries now possible
The Danish Medicines Agency can now receive electronic reports of suspected unexpected serious adverse reactions, also known as SUSARs, from trials in other EU countries. SUSARs that occur in other EU/EEA countries must be reported to the Danish Medicines Agency if the trials have the same protocol (EudraCT number) as in Denmark. The new opportunity of electronic submission applies to precisely these SUSARs.
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01 November 2011 /Authorisation and supervision
Recall of medicines from patients: Truxal® 15 mg tablets with batch number 2282853
The Danish Medicines Agency has been informed that an error has occurred in the manufacturing of Truxal®, an antipsychotic medicine from Lundbeck. All users of Truxal® must therefore check the batch number on their packages. If the batch number is 2282853, the package must be returned to a pharmacy.
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01 November 2011 /Authorisation and supervision
Amendment of executive order on euphoriant substances
As of 27 October 2011, the substances 4-MEC, MPPP and N-ethylbuphedrone are comprised by the Danish executive order on euphoriant substances.
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01 November 2011 /Prices and reimbursement
Decision on general reimbursement for Adenuric®
The Danish Medicines Agency has completed its review of an application for general reimbursement for Adenuric®. The product is neither eligible for general nor general conditional reimbursement. Adenuric® is used for treatment of chronic hyperuricaemia (primarily gout).
