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23 December 2011 /Side effects and trials
EMA to review benefits and risks of blood pressure medicines containing aliskiren
Yesterday, the European Medicines Agency (EMA) started reviewing the benefits and risks of blood pressure medicines that contain aliskiren. Based on the present knowledge, the Danish Medicines Agency does not find that there is cause to review the patients’ treatment urgently.
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21 December 2011 /Product areas
Patients treated with Visco Supreme may claim compensation via the Danish Patient Insurance Association
The Danish Medicines Agency has received 44 reports on cases of infection of the interior of the eye (endophthalmitis) following treatment with Visco Supreme (batch nos.11A03 and 11D04) from CLR Medicals International Inc. A total of 93 treatments were made with the products in question.
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21 December 2011 /Side effects and trials
EMA confirms a positive benefit-risk balance of medicines containing growth hormone (somatropin)
After completing a review of all available data on medicines containing growth hormone (somatropin), the European Medicines Agency (EMA) confirms that the benefits of these medicines still outweigh their risks.
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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 /Prices and reimbursement
Changed practice for single reimbursement for hyaluronic acid
In collaboration with the Reimbursement Committee, the Danish Medicines Agency has decided to change the practice for granting single reimbursement for hyaluronic acid. As of 15 January 2012, we will only grant single reimbursement for hyaluronic acid in exceptional circumstances and not, as we have done thus far, to all patients with osteoarthritis of the knee. In the period up until 15 January 2012, we will introduce a time limit on single reimbursement grants for hyaluronic acid to patients with knee osteoarthritis. In Denmark, hyaluronic acid is available as the two medicines Hyalgan® and Artz®, and they are used for patients with knee osteoarthritis for alleviating pain and improving the function of the knee joint.
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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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07 December 2011 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of citalopram
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for citalopram. The Danish Medicines Agency has now translated this recommendation into Danish. The text is used to prepare new product information. Furthermore, marketing authorisation holders of citalopram must implement the new text by submitting variation applications for all relevant products.
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07 December 2011 /Side effects and trials
Improved guidance on the definition of a clinical trial of medicinal products
The Danish Medicines Agency acknowledges that it is often difficult to find out whether or not a trial is to be classified as a clinical trial of medicinal products. We have therefore updated chapter 1 of our Guideline for applications for authorisation of clinical trials of medicinal products in humans and have also included some examples of what is not a clinical trial. Along with the update, we have published information that can help researchers find out whether a trial is a clinical trial of medicinal products or possibly a non-interventional study.
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07 December 2011 /Authorisation and supervision
Translation of the PhVWP's recommendation for product information concerning use of antipsychotics during pregnancy
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for antipsychotics. The Danish Medicines Agency has now translated this recommendation into Danish. The text is used to prepare new product information. Marketing authorisation holders of antipsychotics must implement the new text by submitting variation applications for all relevant products.
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01 December 2011 /News - miscellaneous
Danish Pharmacovigilance Update, 17 November 2011
In this issue of Danish Pharmacovigilance Update, you can read about domperidone (Motilium® etc.) and potential risk of cardiac disorders, about the European Medicines Agency's recommendation on a lower dose of the antidepressant citalopram as well as about more interesting aspects of pharmacovigilance.
