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07 February 2012 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance trimetazidine dihydrochloride
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): CEP R0-2007-254-Rev01 trimetazidine dihydrochloride.
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07 February 2012 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance erythromycin
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the Certificate of Suitability for the active substance erythromycin.
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06 February 2012 /Authorisation and supervision
Fewer organisations need a section 39 authorisation for retail sale of medical gases
In future, an organisation must actually sell medical gases to users in order to be considered a retailer of medical gases, which requires an authorisation under section 39 of the Danish Medicines Act.
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31 January 2012 /Authorisation and supervision
New revised Danish translation of the PhVWP's recommendation for the product information of ophthalmic beta-blockers
The European Pharmacovigilance Working Party, PhVWP, has once again revised its recommendation for the wording of the product information for ophthalmic beta-blockers. The package leaflet has been revised in order to bring the contraindications into agreement with item 4.3 of the summary of product characteristics.
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25 January 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of Strattera (atomoxetine)
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for Strattera (atomoxetine). The Danish Medicines Agency has now translated this recommendation into Danish.
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20 January 2012 /Authorisation and supervision
Updating of summaries of product characteristics prompted by changed ATC codes for 2012
Marketing authorisation holders of medicinal products authorised under the Decentralised Procedure and the Mutual Recognition Procedure should be aware that some ATC codes have been changed in 2012.
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10 January 2012 /Authorisation and supervision
Danish Medicines Agency resumes allocation of DCP time slots for the period July-October 2012
From 16 January until 6 February 2012, the Danish Medicines Agency accepts request for DCP time slots with Denmark as reference member state (RMS) for the period July-October 2012.
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02 January 2012 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for a number of active substances
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP): CEP 2001-341-Rev 02/Azathioprine, CEP 2003- 066-Rev 00/Ticlopidine HCl, CEP 2003-206-Rev 00/Haloperidol, CEP 2004-135-Rev 01/Risperidone, and CEP 2005-084-Rev 00/Diphenoxylate HCl. The manufacturer concerned is: RPG Life Sciences Limited, 25, M.I.D.C Land, Thane Belapur Road, 400 705 Navi Mumbai, Maharashtra, India.
