Problems receiving emails from external parties
Danish Medicines Agency The Danish Medicines Agency is currently experiencing problems receiving emails from external parties. Go to Source 31/03/2023 – 12:03 / Twitter: @hoffeldtcom
How serious is Danish recall of antibiotic medicine?
The Local The Danish Medicines Agency, Lægemiddelstyrelsen, recently recalled antibiotic medicine Dicillin. Go to Source February 8, 2023 – 6:14 pm / Twitter: @hoffeldtcom
Multi-stakeholder platform to improve clinical trials in the EU – Public consultation
Danish Medicines Agency As part of the Accelerating Clinical Trials in the EU (ACT EU) initiative, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European Commission (EC) are establishing a multi-stakeholder platform to improve clinical trials in the European Union (EU). The multi-stakeholder platform will support discussions across the clinical […]Continue reading
Danish medicines authority recalls antibiotic used by 35,000 people
The Local The Danish Medicines Agency, Lægemiddelstyrelsen, said on Monday that persons using the antibiotic medicine Dicillin, produced by Sandoz, should return it to pharmacies to be replaced. Go to Source February 6, 2023 – 9:03 pm / Twitter: @hoffeldtcom
Recall of the antibiotic Dicillin from Sandoz
Danish Medicines Agency Patients who are treated with Dicillin Sandoz 500 mg capsules are instructed to return the medicine to a pharmacy and have it replaced. It is important not to stop treatment but to have the medicine replaced with another antibiotic. The pharmacies have been informed to dispense an alternative medicine. Go to Source […]Continue reading
Order books and Procedure Start Table
Danish Medicines Agency In order to improve the companies’ possibility to follow the status of their submitted variations, the Danish Medicines Agency is expanding its order book for variations to include all national type I Go to Source January 12, 2023 – 3:04 pm / Twitter: @hoffeldtcom
Updating of summaries of product characteristics due to changed ATC codes for 2023
Danish Medicines Agency Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2023. Go to Source January 2, 2023 – 3:10 pm / Twitter: @hoffeldtcom
The Danish Medicines Agency suspends the Danish marketing authorisations of four generic medicines
Danish Medicines Agency The European Commission has reached a decision in the case about the bioequivalence company Synchron Research, deciding that a number of generic medicines must be suspended in the EU counties where they are authorised. The Danish Medicines Agency therefore suspends the marketing authorisations of four medicines. Go to Source December 13, 2022 […]Continue reading
Applications for compassionate use permits on weekdays between Christmas and New Year
Danish Medicines Agency The Danish Medicines Agency will be closed over Christmas and New Year, reopening on 2 January 2023. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines). Go to Source December 2, 2022 – 12:08 pm / Twitter: @hoffeldtcom
Notification of medicine price and assortment changes between Christmas and New Year
Danish Medicines Agency The Danish Medicines Agency is closed between Christmas and New Year. This means that there is no support regarding notification of medicine price and assortment changes from Monday 26 December 2022 to and including 30 December 2022. Go to Source December 2, 2022 – 12:08 pm / Twitter: @hoffeldtcom