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30 January 2012 /News - miscellaneous
No signs of correlation between urine-derived fertility products and Creutzfeldt-Jakob
Foreign reports have described detection of prion in urine-derived fertility hormones, and there have been speculations about a possible association with Creutzfeldt-Jakob Disease. A linkage of Danish registers has provided no basis for such a conclusion.
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26 January 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 19 January 2012
In this issue of Danish Pharmacovigilance Update read about the risk that patients treated with statins develop diabetes, and proton-pump inhibitors (PPI) and the risk of hypomagnesaemia with long-term use.
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09 January 2012 /News - miscellaneous
Still possible to report suspected illegal activities with medicines anonymously
At the end of 2010, the Danish Medicines Agency made it possible for people to file an anonymous report on suspected illegal activities with medicines. During 2012, the Danish Medicines Agency will expand the scheme, making it possible to report anonymously any illegal activities in areas regulated by the Danish Medicines Agency in the form of medical devices, tissues and cells, etc.
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03 January 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 15 December 2011
Among the topics covered in this issue of Danish Pharmacovigilance Update are: Atomoxetine (Strattera®) and the risk of increased blood pressure and heart rate, increased suspicion of risk of congenital malformations with the antiepileptic topiramate (Topimax® and others), and new recommendations for the antidepressant escitalopram.
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01 December 2011 /News - miscellaneous
Danish Pharmacovigilance Update, 17 November 2011
In this issue of Danish Pharmacovigilance Update, you can read about domperidone (Motilium® etc.) and potential risk of cardiac disorders, about the European Medicines Agency's recommendation on a lower dose of the antidepressant citalopram as well as about more interesting aspects of pharmacovigilance.
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09 November 2011 /News - miscellaneous
Danish Pharmacovigilance Update, 20 October 2011
In this edition of Danish Pharmacovigilance Update, you can read about: Use of medicines involving a risk of serious and life-threatening skin reactions, the European Medicines Agency to investigate the possible connection between orlistat and rare cases of severe liver toxicity, and the EMA’s review of peritoneal dialysis solutions from Baxter A/S.
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31 October 2011 /News - miscellaneous
FDA seminar on IVD/Medical Device Regulation and Management
On 15 to 16 November, the Danish embassy in Washington D.C. hosts a seminar in collaboration with the U.S. Food and Drug Administration (FDA) and Beaufort Advisors.
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26 September 2011 /News - miscellaneous
Danish Pharmacovigilance Update, 15 September 2011
In this issue of Danish Pharmacovigilance Update, read about a significant increase in off-label use of AeroBec® in children under the age of five, and much more.
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09 September 2011 /News - miscellaneous
Danish Pharmacovigilance Update, 18 August 2011
Among the topics covered in this issue are Vimpat® 15mg/ml syrup (lacosamide) for treatment of epilepsy, which is recalled due to a quality defect and Nplate® (romiplostim), which could increase the risk of disease progression in patients with myelodysplastic syndrome (MDS).
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22 August 2011 /News - miscellaneous
Indication, 30 June 2011
In the June issue, catch up on the amendments to the Danish Medicines Act and more.
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19 August 2011 /News - miscellaneous
Continued fall in lice medicines sales in Denmark
In Denmark, August marks the prime time for head lice infestation when kids meet up at school after their holidays. But despite the increase in head lice attacks, sales of head lice medicines are headed opposite, as revealed by declining sales of the authorised medicines (Nix® and Prioderm®). And so, last year's falling trend continues.
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12 August 2011 /News - miscellaneous
Report on the blood product area in 2010
In 2010, 337,000 blood collections were made in Denmark. This is approximately 21,000 collections less than the previous year.
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27 June 2011 /News - miscellaneous
Danish Pharmacovigilance Update, 16 June 2011
Among the articles in this issue of Danish Pharmacovigilance Update, you can read about the removal of contraindication for Velcade® (bortezomib) used for the treatment of multiple myeloma.
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23 June 2011 /News - miscellaneous
Urine-derived fertility medicines are still safe
The Danish Medicines Agency has been made aware of a recent discussion on Facebook about detection of prions (naturally occurring proteins) in urine-derived fertility medicines and a discussion of the medicine's safety. The Danish Medicines Agency advises that the prions in urine-derived fertility medicines that we referred to in our announcement on 2 May 2011 have not been associated to diseases - including the brain disease Creutzfeldt-Jakob disease.
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22 June 2011 /News - miscellaneous
Indication, 27 May 2011
The May issue of the Danish Medicines Agency's newsletter Indication has now been issued. In the newsletter, you can read that medstat.dk has been improved. It is now easier to gain access to statistics on the sale of medicines in Denmark.
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01 June 2011 /News - miscellaneous
Danish Pharmacovigilance Update, May 2011
Among the articles in this issue of Danish Pharmacovigilance Update is a status on adverse reaction reports for contraceptive pills.
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13 May 2011 /News - miscellaneous
Danish Pharmacovigilance Update, April 2011
In this issue of Danish Pharmacovigilance Update, read about a new contraindication for Telzir® (fosamprenavir) for HIV treatment, reports of blood clots from the use of Vivaglobin®, and new, improved e-forms for reporting suspected adverse reactions and much more.
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02 May 2011 /News - miscellaneous
Detection of prion protein in urine-derived hormonal preparations does not give rise to discourage use
A recent article from a French/American/Canadian team of researchers explains detection of prion protein in a number of urine-derived hormonal preparations for the treatment of female infertility.
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19 April 2011 /News - miscellaneous
Special edition of Indication about Per Helboe
This issue of the newsletter is a special edition about Senior Director of Division Per Helboe in honour of his retirement in April, this year.
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15 April 2011 /News - miscellaneous
Indication, march 2011
In this issue of Indication you can read about The Danish Medicines Agency's new strategy, how companies and scientists can save resources by applying for approval of a clinical trial through the European Voluntary Harmonisation Procedure, the daily work of evaluating serious side effects, and whether the differences between men and women should be reflected in the development of new medicines.
