23 December 2011 /Side effects and trials
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.
21 December 2011 /Side effects and trials
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.
07 December 2011 /Side effects and trials
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.