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28 August 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information - carbamazepine
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for carbamazepine.
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22 August 2012 | Updated 27 August 2012 /Product areas
Danish hospitals advised to call in women having received synthetic mesh implants
The Danish Health and Medicines Authority advises Danish hospitals to call in women who have received surgical mesh for pelvic organ prolapse for consultation, examination and evaluation.
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21 August 2012 /Authorisation and supervision
Tests of glycerol used in magistral formulations and marketed medicinal products
Supplementing the enhanced control of active substances (the API project), the Danish Health and Medicines Authority has recently put increased focus on further testing of excipients. The Danish Health and Medicines Authority's laboratory has analysed the excipients glycerol and glycerol 85%. Samples of the excipient have been submitted by pharmacies that perform magistral formulations and by companies with marketed medicinal products. Analyses have been performed on glycerol batches from seven pharmacies and five companies.
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17 August 2012 /Product information
Do not use Spektramox 50 mg/ml +12.5 mg/ml with batch numbers 96629 and 96630
There is a risk that plastic pieces could be present in Spektramox 50 mg/ml + 12.5 oral solution with batch numbers 96629 and 96630, and consumers in Denmark who, during the past seven days, have received this product should return it to a pharmacy for replacement.
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10 August 2012 /Authorisation and supervision
Closer attention to guidelines on submission of electronic applications for marketing authorisations
Our guidelines on submission of electronic applications to the Danish Health and Medicines Authority have been available on our website for some time, but we wish to draw attention to them once again As we have received a number of incorrect submissions.
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03 August 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 21 June 2012
Among the topics covered in this issue of Danish Pharmacovigilance Update are: Decrease in the number of intoxications and suicide attempts using drugs containing acetylsalicylic acid or paracetamol.
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31 July 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 24 May 2012
Among the topics covered in this issue of Danish Pharmacovigilance Update are: Drug Analysis Prints involving data from more than 14,000 Danish adverse reaction reports available at the Danish Health and Medicines Authority’s website.
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27 July 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – July 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 16-18 July 2012.
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25 July 2012 /Side effects and trials
Sun, heat and medicine
Various medicines can make your skin more sensitive to sunlight (photosensitivity), and it concerns both medicines in tablet form and other forms, such as creams. You should therefore protect yourself from the sun by wearing clothes, a hat or by using a good sunscreen if you take medicine that makes your skin more sensitive to light.
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12 July 2012 /Authorisation and supervision
Assessment times for authorisation of medicines for the first six months of 2012
We have published our assessment times for authorisation of medicines for the first six months of 2012.
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10 July 2012 /Product areas
Surgery with the da Vinci Surgical System resumed in Denmark
Robotic surgery using the da Vinci Surgical System will resume Tuesday 10 July in Denmark, after having been halted for the past two weeks. The decision to resume surgery with the da Vinci Surgical System was taken by the five national robot centres based on an independent investigation and further documentation from the manufacturer Intuitive Surgical.
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10 July 2012 /News - medical devices
Surgery with the da Vinci Surgical System resumed in Denmark
Robotic surgery using the da Vinci Surgical System will resume Tuesday 10 July in Denmark, after having been halted for the past two weeks. The decision to resume surgery with the da Vinci Surgical System was taken by the five national robot centres based on an independent investigation and further documentation from the manufacturer Intuitive Surgical.
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05 July 2012 /Authorisation and supervision
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 /Authorisation and supervision
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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05 July 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – June 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 18-20 June 2012.
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07 June 2012 | Updated 04 July 2012 /About us
New opening hours from 2 July 2012
As part of the merger announced earlier this year, the Danish Health and Medicines Authority introduced new opening hours as of 2 July 2012.
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04 July 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 19 April 2012
Among the topics covered in this issue of Danish Pharmacovigilance Update are: Split and crushed tablets containing finasteride may pose a risk for pregnant and fertile women.
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03 July 2012 /Side effects and trials
New study on treatment with HES (hydroxyethyl starch) in patients with severe sepsis
A new Danish study published in the New England Journal of Medicine has investigated HES used as a plasma substitute in patients with severe sepsis. The study followed 800 patients from intensive care units in Denmark, Iceland, Norway and Finland over a two-year period. The conclusions of the study suggest that HES has a less favourable safety profile than Ringer's acetate used as plasma substitutes in patients with severe sepsis.
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29 May 2012 | Updated 27 June 2012 /Legislation
New European legislation improves the monitoring of adverse reactions and strengthens patient safety
In July 2012, new pharmacovigilance legislation comes into effect across the EU. The purpose of the new legislation is to strengthen patient safety by improving the present system used for monitoring safety of medicines in Europe.
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25 June 2012 /Legislation
Publication of EU Implementing Regulation on the performance of pharmacovigilance activities
On 20 June 2012, the European Commission's Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council was published in the Official Journal of the European Union.
