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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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23 November 2011 /Product areas
Eye surgical solution recalled due to risk of inflammation within the eyeball
The Danish Medicines Agency has received reports of at least five cases of inflammation within the eyeball (endophthalmitis) caused by the use of a specific consignment of the product Visco Supreme from CLR Medicals International Inc. (lot no.11A03).
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21 November 2011 /About us
More digital services on DKMAnet: company authorisations, clinical trials and follow-up on adverse reaction reports
We are pleased to announce the expansion of the Danish Medicines Agency's extranet, DKMAnet, which offers electronic self-service solutions for companies. DKMAnet is expanded today, 21 November, with three new areas: company authorisations, clinical trials of medicines for human use, and follow-up on adverse reaction reports.
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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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18 November 2011 /Side effects and trials
Pradaxa (dabigatran etexilate) – remember to assess renal function
At a meeting held 17-20 October 2011, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), strengthened the instructions for doctors' use of dabigatran etexilate with particular focus on patients with impaired renal function.
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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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15 November 2011 /Prices and reimbursement
Review concluded regarding general reimbursement for Adepend®
The Danish Medicines Agency has completed its review of an application for general reimbursement for Adepend®. The product is neither eligible for general nor general conditional reimbursement. Adepend® is used as part of treatment of alcoholism. When we compare treatment with Adepend® with treatment with Antabuse, we assess that the price of the medicine is not reasonable relative to its therapeutic value.
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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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11 November 2011 /Prices and reimbursement
Review concluded regarding general reimbursement for Xiapex®
The Danish Medicines Agency has completed its review of an application for general reimbursement for Xiapex®. The product is neither eligible for general nor general conditional reimbursement. Xiapex® is indicated for the treatment of Dupuytren's contracture.
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01 November 2011 | Updated 09 November 2011 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – October 2011
The EU Pharmacovigilance Working Party (PhVWP) convened on 17-19 October 2011. On the meeting's agenda was antiepileptics, citalopram and domperidone.
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09 November 2011 /News - miscellaneous
Danish Pharmacovigilance Update, 20 October 2011
In this edition of Danish Pharmacovigilance Update, you can read about: Use of medicines involving a risk of serious and life-threatening skin reactions, the European Medicines Agency to investigate the possible connection between orlistat and rare cases of severe liver toxicity, and the EMA’s review of peritoneal dialysis solutions from Baxter A/S.
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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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08 November 2011 /Retail and online sale
Still more types of illegal medicine sold in creative packages online
Over the past six months, the Danish Medicines Agency has withheld an increasing number of different products in customs. Many of them appear to be common food products or food supplements, but in fact they contain medicine, and this is not written on the package. For example, it can be sachets with powder that can be added to juice or milkshakes – or coffee with medicine in it.
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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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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.
