News about medicines safety
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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 report on adverse reactions reported with tramadol for pain relief
| 20 December 2018 |
The Danish Medicines Agency has received 830 reports of suspected adverse reactions with tramadol since the medicine was marketed in March 1993. 155 of them describe symptoms of dependence. This follows from a report that has just been published. In 2017, about 265,000 individuals received treatment with tramadol in Denmark.
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Medicines of the future in focus at World Economic Forum
| 20 September 2018 |
Medicines of the future is one of the topics being debated at the meeting of the World Economic Forum, which is currently place right now in Tianjin in China. The Danish Medicines Agency is attending.
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Be aware of rare but possible risk of liver injury in medical treatment of fibroids
| 15 February 2018 |
The Danish Medicines Agency recommends doctors not to start any new patients on the medicine Esmya (ulipristal) because of a rare, but possible, risk of developing serious liver injury.
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New practice for follow-up information on adverse reaction reports
| 29 September 2017 |
The Danish Medicines Agency has introduced a new practice for the processing of pharmaceutical companies' requests for follow-up information on reports of suspected adverse reactions.
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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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Interactive Adverse Drug Reaction overviews
| 08 December 2016 |
The Danish Medicines Agency has launched a new web-based database that researchers and other interested parties can use to search for reported suspected adverse reactions.
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How the HPV vaccine works
| 30 November 2016 |
The Danish Medicines Agency has made a short video graphic about the efficacy of the HPV vaccine.
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Efficacy of emergency contraception may be reduced when taken with other medicines
| 08 August 2016 |
Women seeking the Norlevo or Levodonna emergency contraceptives should be aware that the efficacy may be reduced when taken with other medicines.
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Public funds allocated for research into possible adverse reactions from HPV vaccination
| 08 July 2016 |
Three projects will receive public funds of DKK 7 million, which the Danish Parliament has earmarked for research into possible adverse reactions from HPV vaccination.
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Nine applications for funds earmarked for research in HPV adverse reactions
| 12 May 2016 |
The Danish Parliament has earmarked an amount of DKK 7 million for research into possible adverse reactions from the HPV vaccines. The deadline for applications has expired and the applications will now be reviewed by Innovation Fund Denmark.
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EMA: No changes to the safety profile of Gardasil
| 09 February 2016 |
The European Medicines Agency (EMA) has recently completed its annual routine safety assessment of the HPV vaccine Gardasil®. The conclusion is that there are no changes to the safety profile.
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The Danish Medicines Agency has a new website
| 04 January 2016 |
Today, the Danish Medicines Agency launched its new website – laegemiddelstyrelsen.dk/en – where you can read about and subscribe to news about licensing and supervision of medicines, side effects, reimbursement, pharmacies and medical devices.