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21 December 2011 /Authorisation and supervision
Recall of Vistide® deliveries causes no supply issues
The European Medicines Agency (EMA) has found that quality issues may have arisen in the production of the medicine Vistide® from the US company Ben Venue. EMA has therefore recommended that the company recall all affected deliveries (batches) of Vistide® until the quality can be assured.
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12 December 2011 /Authorisation and supervision
No supply problems caused by recall of batches of Luminity® and Ecalta®
The European Medicines Agency (EMA) has found that a quality problem may have occurred during the manufacturing of the two medicines Luminity® and Ecalta® from the US-based company Ben Venue.
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23 November 2011 /Authorisation and supervision
The use of Caelyx® should be limited due to quality issue
The European Medicines Agency (EMA) recommends doctors to limit the use of the medicine Caelyx® due to a potential quality issue during the manufacturing process at the US-based company Ben Venue.
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23 November 2011 /Authorisation and supervision
No supply problems caused by recall of batches of Busilvex®, Velcade® and Vidaza®
The European Medicines Agency has found that a quality problem may have occurred during the manufacturing of three medicines Busilvex®, Velcade® and Vidaza® at the US-based company Ben Venue. EMA has therefore recommended that the company recall all affected batches of the three medicines until the required quality assurance has been established.
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21 November 2011 /Authorisation and supervision
Withdrawal of a medicine due to possible counterfeiting
The pharmaceutical company Orifarm has – in consultation with the Danish Medicines Agency – decided to withdraw the medicine Truvada®. The withdrawal is caused by a potential presence of counterfeit packs on the market.
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09 November 2011 /Authorisation and supervision
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 /Authorisation and supervision
Warning on illegal sale of donor sperm from saedbank.com
The Danish Medicines Agency has twice before warned against the sperm bank A. I. Sædbank, which yet again sells donor sperm illegally from the website www.saedbank.com. The website has been inactive for a period, but is now active again. According to the information on the website, the sperm bank supplies donor sperm for persons in the former Aarhus County.
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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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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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27 October 2011 /Authorisation and supervision
Spot checks reveal insufficient information about antidepressants for pregnant and breast-feeding women
The Danish Medicines Agency has reported a number of companies to the police for having failed to update the package leaflet regarding pregnant and breast-feeding women's use of antidepressants of the SSRI type (selective serotonin reuptake inhibitors). At the same time, the Danish Medicines Agency has instructed the companies to withdraw any SSRIs with inadequate warnings.
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26 October 2011 /Authorisation and supervision
No cause for concern about influenza vaccination
A single batch of the influenza vaccine Preflucel has been withdrawn from the Danish market. 14 vaccines have been used in Denmark, and all other unused vaccines have been withdrawn from the market. There have been no reports of side effects in Denmark.
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24 October 2011 /Authorisation and supervision
Statement from EMA about Advagraf® and cardiovascular medicine
The European Medicines Agency, EMA, has decided to immediately recall some batches of Advagraf® (tacrolimus) 0.5 mg prolonged-release hard capsules from pharmacies and wholesalers from a number of countries across the EU. EMA has also looked into the possible link between the use of blood pressure lowering medicines of the type angiotensin II receptor antagonists and the occurrence of new incidences of cancer. EMA found that the evidence does not suggest any link with cancer.
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07 October 2011 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance oxytetracycline
The European Directorate for the Quality of Medicines and Healthcare, has suspended the Certificate of Suitability for oxytetracycline.
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06 May 2011 | Updated 30 September 2011 /Authorisation and supervision
Errors found at more than one in five alternative practitioners
More than one in five alternative practitioners visited by the Danish Veterinary and Food Administration and the Danish Medicines Agency in a series of joint on-site inspections last year were unfamiliar with the regulations for the food supplements and medicines on their shelves. This is the result of a report based on more than 50 on-site inspections at alternative practitioners across Denmark.
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20 September 2011 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance theophylline
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended Theophylline.
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20 September 2011 /Authorisation and supervision
The EDQM has suspended the Certificates of Suitability for the active substances ribavirin and tiamulin
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended Tiamulin Hydrogen for veterinary use and Ribavirin.
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22 July 2011 /Authorisation and supervision
Annual report 2010 of the Danish Medicines Agency's laboratory control activities
The Danish Medicines Agency's Laboratory has published an annual report for 2010 that describes our activities within the European network called the Official Medicines Control Laboratories (OMCL).
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14 June 2011 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance mesalazine
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP): CEP 2005-277 / Mesalazine
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15 April 2011 /Authorisation and supervision
The EDQM has suspended the Certificates of Suitability for the active substances buprenorphine hydrochloride, fentanyl, buprenorphine and naltrexone hydrochloride
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended the following Certificates of Suitability (CEP): buprenorphine hydrochloride, fentanyl, buprenorphine og naltrexone hydrochloride
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10 March 2011 /Authorisation and supervision
Issuance of GMP certificates in relation to GMP inspection
The Danish Medicines Agency issues a GMP certificate or a statement of non-compliance with GMP within 90 days after a GMP inspection (inspection of good manufacturing practice). This is done in accordance with the agreed European procedures for inspectorates.
