News from the Danish Medicines Agency
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Suspicion of rare eye condition from Ozempic use to be investigated further
| 16 December 2024 |
The Danish Medicines Agency will request the European Pharmacovigilance Risk Assessment Commit-tee, PRAC, to assess two new Danish register-based studies from the University of Southern Denmark. The studies point to a potential increased risk of a rare eye condition, NAION, in patients receiving the diabetes medicine Ozempic.
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Danish Medicines Agency closed over Christmas and New Year
| 10 December 2024 |
The Danish Medicines Agency will be closed over Christmas and New Year, from Tuesday 24 December 2024 to Wednesday 1 January 2025, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2024.
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Common nordic packages for better availability
| 02 December 2024 |
Starting from the new year, a pilot project will introduce English-language common nordic packages. This aims to improve the availability by simplifying production and distribution.
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Nils Falk Bjerregaard new Director General of the Danish Medicines Agency
| 03 October 2024 |
The Danish Ministry of the Interior and Health has appointed Medical Director Nils Falk Bjerregaard as Director General of the Danish Medicines Agency as of 1 November 2024.
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New regulations on Stockpiling of Critical Medicines effective on July 1 2024
| 01 July 2024 |
It will soon be mandatory for companies behind the most critical medicines to maintain stocks to cover initially six weeks’ consumption and to report stocks regularly to the Danish Medicines Agency. The affected companies will have six months to prepare for compliance, and, in August, the Danish Medicines Agency is holding information meetings about the new rules.
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Danish Medicines Agency establishes that chronic urticaria could be a side effect of the Spikevax vaccine
| 05 April 2024 |
The European Pharmacovigilance Risk Assessment Committee (PRAC) has reassessed if chronic urticaria could be a side effect after vaccination with the Spikevax vaccine from Moderna. This follows a review from the Danish Medicines Agency, which has investigated data and reports from patients across the European countries.
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Danish Medicines Agency closed over Christmas and New Year
| 28 November 2023 |
The Danish Medicines Agency will be closed over Christmas and New Year, from Saturday 23 December 2023 to Monday 1 January 2024, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2023.
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First electronic product information published for medicines
| 09 November 2023 |
Four EU countries – including Denmark – have published the first versions of digital product information for selected medicines. A pilot initiative is right now testing the use of digital product information for medicines used by citizens and healthcare professionals throughout the EU.
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More reports at the beginning of the vaccination programme, but no suspicion of safety differences between COVID-19 vaccine batches
| 01 November 2023 |
A new analysis from the Danish Medicines Agency shows that the number of reports of suspected side effects after vaccination with COVID-19 vaccines is highly related to the time the individual vaccine batches were used.
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Danish Medicines Agency releases COVID-19 vaccine batch from quarantine
| 20 October 2023 |
On 17 October, the Danish Medicines Agency decided to quarantine a specific batch (batch HG2252) of COVID-19 vaccines from Pfizer/BioNTech. Since then, the Danish Medicines Agency and Pfizer have worked together to review the documentation of the batch in question, based on which the agency has now decided to release said batch from quarantine.
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Covid-19 vaccine batch in quarantine
| 18 October 2023 |
As a precautionary measure, the Danish Medicines Agency has decided to quarantine a specific batch of COVID-19 vaccines from Pfizer/BioNTech in response to vaccine centres having observed a possible error when using a specific vaccine batch. Over the next days, some people will therefore experience having their vaccination appointment cancelled. At present, there are no signs of any impact on the efficacy and safety of the batch in question.
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The Danish Medicines Agency suspends the Danish marketing authorisations of four generic medicines
| 15 March 2023 |
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.
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Recall of the antibiotic Dicillin from Sandoz
| 07 February 2023 |
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.
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Operation PANGEA 2022: 500 packages seized in the customs and 35 websites reported to the police for illegal trading in pharmaceuticals
| 28 July 2022 |
The last days of June saw the roll out of the 2022 version of the Interpol-managed Operation Pangea XV – a global initiative targeted illegal trade with medicines and medical devices. The Danish Medic
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New executive order raises fees in the area of the Danish Medicines Agency
| 03 May 2022 |
Higher fees become payable for medicinal products and pharmaceutical companies as a result of a new executive order entering into force on 1 May 2022. The last time the fees were adjusted was in 2017.
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Danish Medicines Agency presents new strategy
| 05 April 2022 |
Lars Bo Nielsen, Director General of the Danish Medicines Agency, announces new 2022-26 strategy for the agency. The strategy supports the Danish Ministry of Health’s joint corporate strategy and emphasises a vision to lead national and international collaboration, for example regarding better use of data and new technology and dialogue with public and society in general.
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Danish Medicines Agency closed over Christmas and New Year
| 15 December 2021 |
The Danish Medicines Agency will be closed over Christmas and New Year, from Friday 24 December 2021 to Sunday 2 January 2022, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2021.
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EMA is evaluating Moderna’s COVID-19 vaccine for children aged 6 to 11
| 12 November 2021 |
Moderna has submitted an application to the European Medicines Agency, EMA, to extend its conditional authorisation for its COVID-19 vaccine, Spikewax, to children aged 6 to 11.
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Danish Medicines Agency investigates a case of inflammatory condition reported after COVID-19 vaccination
| 26 August 2021 |
In collaboration with the EMA, the Danish Medicines Agency is investigating whether the rare inflammatory condition of MIS-C, previously observed as an aftereffect of COVID-19 infection in children and adolescents, can also occur after vaccination. While no causality with the vaccine has been established, it cannot be excluded either.
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New campaign aimed at doctors: High-quality ADR reports make a difference
| 09 July 2021 |
The monitoring of the safety of COVID-19 vaccines over the last months has shown us just how important the reports on suspected side effects from doctors are. A new campaign to promote the quality of ADR reports submitted by doctors sets out to improve the monitoring of medicine safety even further.