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Danish Medicines Agency launches new concept for National Scientific Advice
| 31 August 2018 |
Today, 31 August 2018, the Danish Medicines Agency is launching a new concept for National Scientific Advice for companies, hospitals and others who request advice on the requirements applicable to clinical investigation and marketing authorisations.
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New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones
| 28 August 2018 |
The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.
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Companies can now apply for authorisation to produce cannabis bulk and cannabis primary products
| 21 August 2018 |
On 1 July 2018, a new executive order entered into force which gives companies the possibility of cultivating medicinal cannabis and producing cannabis bulk and cannabis primary products from Danish-grown cannabis.
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Danish Medicines Agency lands new European chairmanship
| 20 August 2018 |
Nikolai Brun, Director of Medical Evaluation & Biostatistics, has been elected chair of the Task Force on Big Data in the pharmaceutical area. The task force is a collaboration between the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) which is to identify advantages and challenges of using big data for the development of medicine.
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Recall of valsartan blood pressure medicine
| 10 August 2018 |
Impurities that could potentially be harmful to health have been found in variants of medicines containing the active substance valsartan. The medicine is used to treat hypertension and heart failure. Patients treated with these medicines are therefore advised to contact their doctor as soon as possible in order to to be switched to another type of medicine.
