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Testing the exchange of E2B files
| 16 August 2017 |
Testing the exchange of E2B ICSRs/SUSARs between the Danish Medicines Agency and companies/sponsors must be completed by Friday 29 September 2017.
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Bravecto® may cause convulsions in dogs on rare occasions
| 10 August 2017 |
The European Medicines Agency has reviewed the adverse events of Bravecto®, a veterinary medicine used to treat flea and tick infestations in dogs. The conclusion is that the medicine may on very rare occasions cause convulsions in dogs – primarily in dogs with pre-existing epilepsy.
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Withdrawal of one more batch of counterfeit packs of the schizophrenia medicine Xeplion 150 mg
| 01 August 2017 |
German and Danish parallel importers and the Danish Medicines Agency are now withdrawing the fourth batch of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batch contains counterfeit packs.
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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One German and several Danish parallel importers and the Danish Medicines Agency have withdrawn several batches of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batches contained counterfeit packs.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.
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Substantial progress in cooperation with CFDA only six weeks after state visit
| 23 June 2017 |
During the official state visit at the beginning of May, the Chinese and Danish Ministers for Health and Food signed a Memorandum of Understanding about the establishment of the China-Denmark Food and Drug Regulatory Cooperation Centre. Only six weeks after the state visit, the China Food and Drug Administration (CFDA) and the Danish Medicines Agency held a successful seminar on 20 and 21 June in Beijing on the licensing of medicines and the drafting of a work programme with common activities up to and including 2020.
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Evaluation of a Danish meta-analysis of antidepressants
| 21 June 2017 |
The Danish Medicines Agency has evaluated a Danish meta-analysis made by the Copenhagen Trial Unit on the effects of antidepressants (SSRIs). The analysis attracted extensive media coverage.
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Eleven new substances on the list of euphoriant substances
| 16 June 2017 |
On 15 June 2017, 11 new substances were included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health. The information is primarily relevant to companies authorised to deal with euphoriant substances.
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New format requirements for marketing authorisation applications
| 15 June 2017 |
The Danish Medicines Agency is postponing the phasing-out of NeeS and tightens the format requirements for updating the assessment report prior to MRP/RUP.
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Annual report 2016 - Clinical trials of medicines
| 13 June 2017 |
LLast year, the Danish Medicines Agency received 286 clinical trial applications. This is a small decline compared to 2015. However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013.
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Tramadol: It is important that we are informed of side effects
| 13 June 2017 |
Doctors should contact the Danish Medicines Agency if clinical experience shows that the side-effect profile of a medicinal product is not consistent with the summary of product characteristics.
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Extensive modernisation of our IT from 8 June to 13 June
| 08 June 2017 |
The Danish Medicines Agency will launch an extensive modernisation of our IT systems from Thursday 8 June 2017 at 6pm to Tuesday 13 June 2017 at 8am. During this period, you may experience longer response times and some of our IT systems and forms will not be available.
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Danish Pharmacovigilance Update, May 2017
| 08 June 2017 |
The May issue of Danish Pharmacovigilance Update.
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Danish Pharmacovigilance Update, April 2017
| 22 May 2017 |
The April issue of Danish Pharmacovigilance Update.
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Agreement on Chinese-Danish cooperation signed
| 03 May 2017 |
The Danish Medicines Agency and the China Food and Drug Administration have taken an important step towards closer cooperation.
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Danish Pharmacovigilance Update, March 2017
| 18 April 2017 |
The March issue of Danish Pharmacovigilance Update.
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More batches of EpiPen® are withdrawn
| 06 April 2017 |
MEDA has decided to withdraw four more batches of EpiPen®. The withdrawal concerns two batches of EpiPen® 300 micrograms/dose and two batches of EpiPen® Jr 150 micrograms/dose. The latter is used for acute hypersensitivity reactions in children. The reason for the withdrawal is that there is a risk that the auto-injector does not work.
