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Reimbursement status of medicinal products aginst hypertension
| 18 December 2006 |
On 6 March 2006, the Danish Medicines Agency wrote a letter to a number of scientific societies to make them clarify certain aspects of the treatment of hypertension in Denmark.
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Reassessment of ATC group A, Alimentary tract and metabolism
| 18 December 2006 |
At the beginning of 2007, the Danish Medicines Agency is going to begin the reassessment of ATC group A, alimentary tract and metabolism, starting with.
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Consultation on recommended changes of the reimbursement status of lipid-lowering medicinal products
| 18 December 2006 |
At several meetings, the Reimbursement Committee has discussed the reimbursement status of lipid-lowering medicinal products. In its recommendation of 7 September 2006 for the Danish Medicines Agency, the Committee suggests a change of reimbursement status for these medicinal products.
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Reassessment of subgroups in ATC group C
| 24 April 2006 |
The Danish Medicines Agency is just beginning to reassess the subgroups in ATC group C, medicinal products for the cardiovascular system, and for the first three months of 2006 the agency expects to be working with the following six subgroups.
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Letter to scientific societies on treatment of hypertension
| 24 April 2006 |
As part of the reassessment concerning medicinal products' reimbursement status, the Danish Medicines Agency has begun looking at reimbursement status of medicinal products for hypertension.
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Bevilling til Brædstrup Apotek
Lægemiddelstyrelsen har den 12. september 2018 meddelt Kerly Maire Servilieri bevilling til at drive Brædstrup Apotek.
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Danish Medicines Agency shortens the review time for applications for COVID-19 medicine trials
Drug regulatory authorities around the world are taking several steps to speed up the development and availability of medicines to treat and prevent novel COVID-19. The Danish Medicines Agency in Denmark has just implemented an emergency procedure for applications for clinical trials with human subjects.
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EMA: No evidence linking ibuprofen to worsening of COVID-19
The press and social media have raised questions about whether ibuprofen could worsen the condition of patients infected with COVID-19. The European Medicines Agency reports that there is currently no scientific evidence to suggest this. The Data Analytics Center of the Danish Medicines Agency now launches an ultra-quick study.
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Henstilling om, hvordan præparatet remdesivir skal bruges til behandling af COVID-19 i såkaldt compassionate use-programs i EU
Under et ekstraordinært møde, der blev afholdt den 2. april 2020, gav det europæiske medicinalagentur EMA's humane lægemiddeludvalg (CHMP) henstillinger om, hvordan præparatet remdesivir skal bruges til behandling af COVID-19 i såkaldt compassionate use-programs i EU, dvs. via udleveringstilladelser.
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COVID-19: Restriction on OTC medicines lifted
The Danish Medicines Agency lifts the restriction on over-the-counter (OTC), which has been in force since March. This means that pharmacies, supermarkets, kiosks and others with permission to sell OTC medicines can resume selling more than one pack of the same type of OTC medicine per customer.
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EMA recommends conditional authorisation of the COVID-19 vaccine from Moderna
The European Medicines Agency, EMA, has recommended the European Commission to grant a conditional authorisation for the COVID-19 vaccine for use throughout the European Union, including Denmark.
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European Commission authorises one more COVID-19 vaccine
On 6 January 2021, the European Commission granted a conditional marketing authorisation for the COVID-19 vaccine from Moderna. The vaccine has demonstrated a 94 per cent efficacy in trials. The authorisation is valid throughout the European Union including Denmark.
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Thomas Senderovitz leaves the Danish Medicines Agency
Thomas Senderovitz has announced that he is leaving his role as Director General of the Danish Medicines Agency to pursue fresh opportunities.
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Publication of educational materials for centrally authorised medicinal products
From January 1st 2023 and forward – and not retroactively – the Danish Medicines Agency now publishes educational material for medicinal products approved via the centralised procedure.
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Registration of approved pack sizes in the Union Product Database
In accordance with Commission Implementing Regulation (EU) 2021/16 of 8 January 2021, approved pack sizes for veterinary medicinal products must be registered in the Union Product Database (UPD). In connection with the registration of data in UPD, the Danish Medicines Agency has found that information on approved pack sizes in the summary of prouct characteristics (SPC) for veterinary medicinal products is not always complete. Therefore there may be missing information on approved pack sizes in the UPD for some products. Consequently, marketing authorisation holders (MAH) for veterinary medicinal products are encouraged to check the information in the UPD.
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Union Product Database: Deadlines for the Submission of Annual Volume of Sales data for veterinary medicinal products
According to Article 58(12) of Regulation (EU) 2019/6 , all Marketing Authorisation Holders must submit the annual Volume of Sales for each veterinary medicinal product to the Union Product Datab
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New EU rules on falsified medicines
When new EU rules enter into force on 9 February 2019, it will be harder for falsified medicines to reach patients in the EU. The new rules, which introduce new safety features on the packaging of medicines and other measures, are to prevent falsified medicines from entering the legal supply chain of medicines – for example in pharmacies and hospitals.
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New report: Evaluation of the relationship reform
The framework for collaboration between healthcare professionals and companies has just been evaluated. The evaluation concluded that the rules and administration work well, but compliance with the rules lags behind. There is a need for more information to healthcare professionals about the rules.
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Danish Medicines Agency to send safety information directly to healthcare professionals
When side effects or the like is discovered for medicines, the medicine’s product information sometimes needs to be changed to the point that healthcare professionals must be informed directly. Up to
