News
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Counterfeit packs of the schizophrenia medicine Xeplion 150 mg
| 27 July 2017 |
One German and several Danish parallel importers and the Danish Medicines Agency have withdrawn several batches of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batches contained counterfeit packs.
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Adverse reaction reports received from the Danish Patient Compensation Association
| 14 July 2017 |
The marketing authorisation holder of a medicinal product shall not submit reports to the Danish Medicines Agency about any adverse reactions appearing from decisions about compensation for medicinal injuries, which the company has received from the Danish Patient Compensation Association.
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The European Commission's decision concerning veterinary medicinal products containing zinc oxide
| 06 July 2017 |
On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.
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New fees for medicinal products, pharmaceutical companies and clinical trials from 1 July 2017
| 03 July 2017 |
On 1 July 2017, a new executive order on fees payable for medicinal products, pharmaceutical companies and clinical trials became effective. The new fees involve changes in a number of areas.
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Adverse event reports for centrally authorised veterinary medicinal products should not be sent to the DKMA
| 03 July 2017 |
The Danish Medicines Agency no longer requests the direct transfer of serious and unexpected third-country adverse event reports for centrally authorised veterinary medicinal products.