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News on product defects and withdrawals of medicinal products
Notifications on suspension of Certificates of Suitability (CEP)
If the EDQM withdraws or suspends a Certificate of Suitability (CEP), the marketing authorisation holder must take the necessary measures to ensure that active substances from the concerned active substance manufacturer are not used, either permanently or for a defined period.
If any medicines on the market contain these active substances from the concerned active substance manufacturer, the marketing authorisation holder must report the product defect to the Danish Health and Medicines Authority at rapidalert@dkma.dk.
You can find more information at the EDQM's website.
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05 July 2012
Suspension of Certificate of Suitability for the active substance Leflunomide
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): CEP 2009-035/Leflunomide.
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05 July 2012
Withdrawal of Certificates of Suitability for the active substances Chlorhexidine digluconate solution and Calcium dobesilate monohydrate
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP): CEP 2005-076-Rev 01/Chlorhexidine digluconate solution and CEP 2010-209-Rev 00/Calcium dobesilate monohydrate.
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22 June 2012
Suspension of Certificates of Suitability for several active substances from the manufacturer Amoli Organics PVT Ltd
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended a number of Certificates of Suitability (CEP):
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22 June 2012
Suspension of Certificate of Suitability for the active substance Povidone iodicated
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP): CEP 2009-166 / Povidone iodicated ...
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08 June 2012 | Updated 13 June 2012
Certificates of Suitability for the active substances Oxytetracycline dihydrate and Oxytetracycline hydrochloride have been withdrawn
Updated: The following Certificates of Suitability (CEPs) have been withdrawn at the request of the manufacturer. CEP 2004-177-Rev 00/ Oxytetracycline dihydrate CEP 2008-165-Rev 00/ Oxytetracycline hydrochloride
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17 April 2012 | Updated 12 June 2012
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24 April 2012
The EDQM has withdrawn the Certificate of Suitability for the active substance Acetylsalicylic acid
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificate of Suitability (CEP): R0-CEP 2006-195-Rev 00 / Acetylsalicylic acid.
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24 April 2012
The EDQM has suspended the Certificate of Suitability for the active substance Stanozolol Micronised
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): R1-CEP 2002-222-Rev 01 / Stanozolol Micronised.
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24 April 2012
The EDQM has withdrawn the Certificate of Suitability for the active substance Oxaliplatin
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificate of Suitability (CEP): R0-CEP 2005-158-Rev 00 / Oxaliplatin.
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18 April 2012
The EDQM has withdrawn Certificates of Suitability for the active substance Diclofenac Sodium
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP): R0-CEP 2006-304-Rev 00 Diclofenac Sodium and R1-CEP 2000-133-Rev 02 Diclofenac Sodium.
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17 April 2012
The EDQM has withdrawn Certificates of Suitability from CSPC Innovation Pharmaceutical Co., Ltd.
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn a number of Certificates of Suitability (CEP) from CSPC Innovation Pharmaceutical Co., Ltd.
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11 April 2012
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 Certificates of Suitability (CEP): RO-CEP 2007-245-Rev 01 Trimetazidine dihydrochloride.
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28 March 2012
The EDQM has suspended the Certificates of Suitability for the active substances Pilocarpine nitrate and Pilocarpine hydrochloride
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEPs): CEP 1997-034-Rev 02 / Pilocarpine hydrochloride and CEP 2002-202-Rev 00 / Pilocarpine nitrate.
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23 February 2012
The EDQM has suspended the Certificates of Suitability for the active substances theophylline, theophylline-ethylenediamine anhydrous and caffeine
The European Directorate for the Quality of Medicines and Healthcare, has suspended the Certificates of Suitability (CEP) for a number of active substances.
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07 February 2012
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
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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02 January 2012
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.
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09 November 2011
Requirement for raised dots led to recalls after spot checks
In June 2010, the Danish Medicines Agency announced that packs of medicine are required to have the medicine's name and strength printed in Braille writing (raised dots) on the outer packaging no later than 30 October 2010 when the medicine is supplied to a wholesaler. The Danish Medicines Agency has carried out spot checks to follow up on the implementation of the requirement on Braille writing. 10 in 518 packs were deficient.
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04 November 2011
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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01 November 2011
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.
