Danish nursing home unit free from MRSA bacteria
The residents and staff at a Danish nursing home unit have been tested for the MRSA bacteria. The test results from the Department of Clinical Microbiology at Odense University Hospital show that the...
View ArticleWe are closed on Friday 20 June from 1 pm
We are closed on Friday 20 June from 1 pm due to a staff event. In urgent matters outside normal opening hours, you can call our 24-hour emergency service
View ArticleGuidelines on applications for authorisation to wholesale distribute...
The Danish Health and Medicines Authority has updated the Guidelines on applications for authorisation to wholesale distribute medicines within the EU/EEA. The guidelines now include guidance to...
View ArticleFocus on correct dose of Pro-Epanutin
The Danish Health and Medicines Authority encourages hospitals to pay special attention to the risk of dose errors of the anticonvulsant medicine Pro-Epanutin. The reason is that the National Agency...
View ArticleChanged procedure for information on duplicate closed and nullified closed...
During the weekend of 28-29 June 2014, the Danish Health and Medicines Authority will implement a new process for dispatching adverse reaction reports (ASPR) to the marketing authorisation holder...
View ArticleMore clinical trials to Denmark
The number of clinical trial applications increased by 35 trials (14%) from 2012 to 2013, which is the highest level in seven years. The increase covers both companies and researchers according to the...
View ArticleMonitoring of medicines for births
The Danish Health and Medicines Authority has prepared a midterm review of the activities in the action plan for Danish regions' use of medicines for the induction of labour. The action plan was...
View ArticleDanish Pharmacovigilance Update May 2014
News from the Eu Assessment of risk of serious anaphylactic reactions from treatment with ferumoxytol (Rienso) The European Medicines Agency, EMA, has started a review of the benefits and risks of...
View ArticleMonthly report from the EU Pharmacovigilance Risk Assessment Committee...
The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 7-10 July 2014. Topics discussed at the meeting: PRAC issues recommendation for oral methadone products containing povidone. PRAC...
View ArticleDanish Pharmacovigilance Update June 2014
News from the EU Potentially life-threatening accidental exposure to fentanyl patches (Durogesic® etc.) Combined use of medicines affecting the renin-angiotensin system (RAS) is restricted EU starts...
View ArticleGood laboratory practice in non-clinical trials
Clinical Trials Facilitation Group (CTFG) has prepared a document describing the requirements as to good laboratory practice (GLP) in non-clinical trials. Applicants are reminded that all pivotal...
View ArticleEbola outbreak in West Africa
The Danish Health and Medicines Authority still assesses that there is a minimum risk that the Ebola haemorrhagic fever will reach Denmark. Denmark has efficient health preparedness plans to detect...
View ArticleHandling of Ebola virus disease
The Danish Health and Medicines Authority has issued guidelines on how to handle the Ebola virus disease. We still assess that the risk of Ebola reaching Denmark is low, and we have efficient health...
View ArticleChange of the HPV vaccination programme to a 2-dose programme
As part of the Danish childhood vaccination programme, girls aged around 12 years are offered HPV vaccine. In future, girls of this age only need two doses of HPV vaccine, compared with three...
View ArticleInvitation to HTA 2.0 Europe – Teaming Up for Value conference
In cooperation with the European Commission, the European network for Health Technology Assessment (EUnetHTA; DHMA is hosting the Secretariat of EUnetHTA) is organising the conference HTA 2.0 Europe –...
View ArticleDanish Pharmacovigilance Update 27 March 2014
In this issue of Danish Pharmacovigilance Update News from the EU Strengthened recommendations for use of zolpidem (Stilnoct® etc.) EU's list of recommendations on safety signals News from the DHMA...
View ArticleItalian case about stolen medicine affects Denmark
21 stolen packages of medicine from Italy have probably been sold on the Danish and German markets. The Danish Health and Medicines Authority has asked the company to recall the medicine (the batch)....
View ArticleConsultation: rules of procedure for public hearings in the EMA
The European Medicines Agency (EMA) has launched a public consultation on draft rules of procedures for public hearings held by its Pharmacovigilance Risk Assessment Committee (PRAC). See the Draft...
View ArticleDanish Pharmacovigilance Update, August 2014
News from the EU Restrictions on the use of bromocriptine (Parlodel®) to inhibit lactation, page 3 EU's list of recommendations on safety signals, page 4 Fluoroquinolones and risk of retinal...
View ArticleMonthly report from the EU Pharmacovigilance Risk Assessment Committee...
The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 8-11 September 2014. Topics discussed at the meeting: PRAC concludes review of Valdoxan/Thymanax (agomelatine). Two years of focus...
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