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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.
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25 November 2011 /Side effects and trials
Atomoxetine (Strattera®) and risk of increased blood pressure and heart rate
In November 2011, the European Pharmacovigilance Working Party (PhVWP) concluded that new knowledge should be communicated about the known risk of increased blood pressure and heart rate associated with the use of atomoxetine, which is authorised for the treatment of ADHD (Attention-Deficit/Hyperactivity Disorder).
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25 November 2011 /Side effects and trials
Tibolone and potential risk of venous thromboembolism, myocardial infarction, breast cancer and ovarian cancer
The European Pharmacovigilance Working Party (PhVWP) has looked at new data from various epidemiological studies on the connection between the use of tibolone, which is authorised for the treatment of symptoms of oestrogen deficiency due to menopause and for the prevention of osteoporosis, and the risk of thromboembolism, myocardial infarction, breast cancer and ovarian cancer.
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25 November 2011 /Side effects and trials
Strengthened suspicion about risk of foetal malformations from use of the antiepileptic topiramate (Topimax® etc.)
It is well-known that use of antiepileptics during pregnancy can cause malformations in the foetus. A recent review of data from two birth registers has reinforced the suspicion concerning the antiepileptic topiramate. The review showed that use of topiramate during the first trimester of pregnancy may cause increased risk of cleft lip and palate, hypospadias and malformations in other parts of the body.
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25 November 2011 | Updated 25 November 2011 /Side effects and trials
New recommendations for escitalopram announced by EMA
In October 2011, the European Pharmacovigilance Working Party, PhVWP, decided that the summaries of product characteristics and package leaflets of medicine containing the antidepressant citalopram must be updated with information on a lower maximum dose. EMA has also reviewed the antidepressant escitalopram and has concluded that the maximum dose of escitalopram should also be reduced.
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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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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.
