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28 October 2011 /Authorisation and supervision
Annual report on human tissues and cells shows continued rise in tissue establishment activity
The annual report on human tissues and cells is now available in English. It shows, among other things, that there were altogether 56 tissue establishments and 40 gynaecology clinics authorised to handle human tissues and cells in Denmark.
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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A single batch of the influenza vaccine Preflucel has been withdrawn from the Danish market. 14 vaccines have been used in Denmark, and all other unused vaccines have been withdrawn from the market.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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26 October 2011 /Authorisation and supervision
Assessment times for authorisation of medicines for the first six months of 2011
We have just published our assessment times for authorisation of medicines for the first six months of 2011.
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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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03 October 2011 /Authorisation and supervision
Changed practice for authorisations for wholesale distribution of medicines within the EU/EEA
The Danish Medicines Agency has changed its practice with respect to the format of authorisations for wholesale distribution of medicines within the EU/EEA. The change concerns the application form's Annex A.1 in which applicants are now only to indicate activities that the company carries out at its own address. Likewise, Annex A.1 of the wholesale dealer's authorisation will only list the activities performed at the company's own address.
