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25 November 2011 /Authorisation and supervision
Difference between the EU and the USA in authorisation of Avastin® (bevacizumab) for metastatic breast cancer
The U.S. Food and Drug Administration (FDA) has revoked the authorisation of Avastin® for use in treating metastatic breast cancer. In the EU, Avastin® is still authorised for treatment of metastatic breast cancer in combination with paclitaxel and in combination with gemcitabine.
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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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15 November 2011 /Authorisation and supervision
Available time slots for DCP procedures with Denmark as Reference Member State (RMS)
The Danish Medicines Agency announces that some DCP procedure time slots have become available in November and December 2011.
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11 November 2011 /Authorisation and supervision
Translation of the PhVWP's recommendation for product information on Stevens-Johnson syndrome and toxic epidermal necrolysis
The European Pharmacovigilance Working Party, PhVWP, has drawn up a recommendation for the wording of the product information concerning Stevens-Johnson syndrome and toxic epidermal necrolysis for high risk medicines.
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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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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.
