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18 December 2009 /Side effects and trials
Side effects from Pandemrix® from 5 to 11 December 2009
In the period from 5 to 11 December, the Danish Medicines Agency received 68 new side effect reports covering a total of 173 suspected side effects (adverse reactions).
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14 December 2009 /Side effects and trials
Side effects from Pandemrix® from 28 November to 4 December 2009
In the period from 28 November to 4 December, the Danish Medicines Agency received 77 new side effect reports covering a total of 224 suspected side effects (adverse reactions).
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05 December 2009 /Side effects and trials
Young children develop good protection from influenza A vaccine - but may have fever
New data show that one single vaccine dose againts influenza A (H1N1) given to children aged from six months to three years provides a good immune response, but that the second vaccine does presumably provides even better protection against the influenza.
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04 December 2009 /Side effects and trials
Side effects from Pandemrix® from 21 to 27 November 2009
In the period from 21 to 27 November, the Danish Medicines Agency received 150 new side effect reports covering a total of 475 suspected side effects
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03 December 2009 /Side effects and trials
The National Board of Health adjusts recommendations on vaccination for influenza A (H1N1)
New data from the European Medicines Agency (EMEA) have shown that it is sufficient to give one dose of vaccine for influenza A (H1N1) for persons with a functional immune system.
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27 November 2009 /Side effects and trials
Side effects from Pandemrix® from 17 to 20 November 2009
In the period from 17 to 20 November, the Danish Medicines Agency received 87 new side effect reports covering a total of 310 suspected side effects (adverse reactions).
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23 November 2009 /Side effects and trials
EMEA: H1N1 vaccine is safe and efficient
The European Medicines Agency (EMEA) has issued a press release stating that a new review of data on Pandemrix® and other vaccines against H1N1 shows that it is sufficient to use a single dose of vaccine for adults, elderly people and children aged 10 and older.
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23 November 2009 /Side effects and trials
European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents
The European Medicines Agency (EMEA) has adopted a set of recommendations aimed at minimising the risk of neophrogenic systemic fibrosis (NSF) with gadolinium-containing contrast agents in patients at risk of developing the condition.
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23 November 2009 /Side effects and trials
Gadolinium and nephrogenic systemic fibrosis: New recommendations from the European Medicines Agency
The European Medicines Agency (EMEA) has adopted new recommendations for the use of gadolinium-containing contrast agents to minimise the risk of a rare adverese reaction, neophrogenic systemic fibrosis (NSF)
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20 November 2009 /Side effects and trials
Side effects from Pandemrix® from 11 to 16 November 2009
In the period of 11 - 16 November, the Danish Medicines Agency received 73 new side effect reports related to the Pandemrix® vaccine against influenza.
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23 November 2009 | Updated 19 November 2009 /Side effects and trials
Tamiflu® for prevention and treatment during an influenza epidemic
Earlier this year, the European Medicines Agency updated the product information for Tamiflu® to ensure that as many people as possible can benefit from the medicine in connection with an influenza epidemic.
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12 November 2009 /Side effects and trials
Side effects from Pandemrix® from 4 to 10 November 2009
The Danish Medicines Agency has received the first side effect reports related to the Pandemrix® vaccine against influenza.
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05 November 2009 /Side effects and trials
Problem regarding receipt of adverse reaction reports now solved
Yesterday and the day before, the Danish Medicines Agency had problems receiving ICSRs and SUSARs via the EudraVigilance gateway, due to an error that occurred in the update of the message format release version.
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28 October 2009 /Side effects and trials
Adverse reactions from Gardasil® in the period 1 May – 31 August 2009
In the period May-August, the Danish Medicines Agency received 69 reports describing 145 suspected adverse reactions. The majority of the reports are not seroius, and the majority (two thirds) of the side effect are already known and described in the summary product characteristics.
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23 October 2009 /Side effects and trials
One dose of Pandemrix® against influenza A (H1N1)v for healthy adults
The Danish National Board of Health has changed its recommendation to one dose of Pandemrix® vaccine against influenza A (H1N1) for healthy adults who are offered the vaccine.
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22 October 2009 /Side effects and trials
Changed definition of safe contraception in clinical trials
We have updated section 5.1 Contraception in the Guideline for applications for authoristaion of clinical trials of medicine product in humans.
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14 October 2009 /Side effects and trials
EU Commission authorises a third vaccine against influenza A (H1N1)
The European Commission has authorised the use of Celvapan® (Baxter) as a vaccine against influenza A (H1N1). The authorisation follows last week's recommendation by the European Medicines Agency (EMEA) to the European Commission to grant a marketing authorisation for the vaccine.
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14 October 2009 /Side effects and trials
Side effects from Eltroxin® - status October 2009
The Danish Medicines Agency has recorde an increase in the number of reported side effects from Eltroxin®. The increase is observed after GlaxoSmithKline (GSK) has changed excipients contained in Eltroxin®.
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06 October 2009 /Side effects and trials
The European Medicines Agency recommends authorisation of another vaccine for pandemic influenza A (H1N1)
The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA) recommends that a marketing authorisation be granted for a third vaccine pandemic influenza A (H1N1).
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01 October 2009 /Side effects and trials
EU Commission authorises two vaccines against influenza A (H1N1)
The EU Commission has authorised the use of two vaccines against influenza A (H1N1). The vaccines concerned are Focetria® (Novartis) and Pandemrix® (GlaxoSmithKline), and Pandemrix® is the one that will be used in Denmark.
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25 September 2009 /Side effects and trials
Survey: Doctors attach great importance to patient safety - a solid foundation to increase side effect reporting
Hospitals are lagging behind in the reporting of side effects. According to a survey conducted by the Danish Medicines Agency, doctors say it is owing to lack of time, focus on the area and knowledge of the rules and procedures.
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25 September 2009 /Side effects and trials
European Medicines Agency recommends authorisation of two vaccines against influenza A (H1N1) 2009
The European Medicines Agency (EMEA) has recommended to the European Commission that two vaccines against influenza A (H1N1) be granted a marketing authorisation.
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01 September 2009 /Side effects and trials
Changed rules for reporting side effects as of 1 September 2009
From now on, doctors, dentists and veterinarians nmust report all suspected serious adverse drug reactions to the Danish Medicines Agency no later than 15 days after they have to their attention.
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31 August 2009 /Side effects and trials
Beware of mix-ups between products containing mirtazapine and mianserin
The Danish Medicines Agency has been informed through the Danish Patient Safety Database of six adverse incidents in the period from March 2007 to June 2009 involving the mix-up of medicines containing the active substances mirtazapine and mianserin.
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27 August 2009 /Side effects and trials
Side effects from medicines used to prevent or treat influenza A (H1N1)
In here you will find the side effects from antiviral drugs such as Tamiflu® and Relenza® and the side effects from the vaccines for the prevention of influenza A (H1N1).
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26 August 2009 /Side effects and trials
About prevention and treatment of influenza
In Denmark, an influenza virus typically occurs every autumn or winter. If you have had the disease - or if you have been vaccinated against it - you will not catch it again the same year/season.
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17 August 2009 | Updated 24 August 2009 /Side effects and trials
Contraceptive pills and the risk of blood clots
A new Danish study confirms that women taking contraceptive pills have an increased risk of blood clots compared to women who do not take contraceptive pills.
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29 July 2009 /Side effects and trials
Update on the safety of insulin glargine (Lantus®)
Recently, the Danish Medicines Agency published a notification on its website on the possible link between treatment with insulin glargine (Lantus®) and the risk of cancer - breast cancer in particular.
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29 July 2009 /Side effects and trials
European Medicines Agency reviews data on vaccines against Influenza A (H1N1)
The European Medicines Agency (EMEA) has started to receive data from the pharmaceutical indsutry on vaccines against Influenza A (H1N1).
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24 July 2009 /Side effects and trials
Adverse reactions from Gardasil® in the period 1 January – 30 April 2009
The HPV vaccine Gardasil® has been introduced in the Danish childhood immunisation programme with the aim of preventing cervical cancer. For the first four months after the introduction Gardasil®, the Danish Medicines Agency received 191 adverse reaction reports describing 280 adverse reactions.
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03 July 2009 /Side effects and trials
Mandatory electronic submission of adverse reaction reports
The Danish Medicines Agency is always looking for ways to improve the processes of adverse reaction reporting. The vast majority of adverse reaction reports associated with medicinal products for human use are submitted electronically by the holders of marketing authorisations in compliance with the provisions of executive order no. 1214 of 7 December 2005 on requirements for the layout of adverse reaction reports and periodic safety update reports.
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01 July 2009 /Side effects and trials
Uncertainty about insulin glargine (Lantus®)
The Danish Medicines Agency has been made aware of four registry studies published on 29 June 2009 in the magazine Diabetologia at the website http://www.diabetologia-journal.org/cancer.html, which investigate a possible link between insulin glargine (Lantus®) and the risk of cancer/breast cancer.
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25 June 2009 /Side effects and trials
European Medicines Agency recommends withdrawal of dextropropoxyphene-containing medicines
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMEA) has recommended that all dextropropoxyphene-containing medicines be withdrawn from the market.
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25 June 2009 /Side effects and trials
EudraCT has been updated to version 7
On 19 June 2009, EudraCT was updated to version 7. Please visit EudraCT's website for an overview of the new functionality.
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19 June 2009 /Side effects and trials
Focus: Hospital doctors to report more side effects
In the past eight years, the number of side effects reported by hospital doctors each year has remained steady at approx. 600, despite a continued increase in medicine consumption and the fact that hospitals admit patients that receive more medicine than other patients.
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03 June 2009 /Side effects and trials
Potential risk of interaction between clopidogrel and proton pump inhibitors
The European Medicines Agency (EMEA) has raised concern about a possible risk of interaction between medicinal products that contain clopidogrel and proton pump inhibitors (PPI).
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13 May 2009 /Side effects and trials
Research opens up questions about Botulinumtoxin A
In a new study in rats, scientists from the Italian Instituto di Neuroscienze in Pisa have discovered that Botulinumtoxin A injected into the jaw muscle of rats had found its way to the rats' brains three day after and that it was still present in the rats' brains after six months.
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06 May 2009 /Side effects and trials
Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications
The Voluntary Harmonisation Procedure is a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.
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16 April 2009 /Side effects and trials
Side effects from Eltroxin® - status April 2009
Recently, the Danish Medicines Agency has recorded an increase in the number of reported side effects from Eltroxin. The increase is observed after GlaxoSmithKline (GSK) has changed the excipients contained in Eltroxin.
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11 March 2009 /Side effects and trials
No new adverse reactions suspected to be associated with the Gardasil® childhood vaccine
This is the statement of the Danish Medicines Agency following close scrutiny of all 174 reported adverse reactiong from the new HPV vaccine against cervical cancer - Gardasil®.
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25 February 2009 /Side effects and trials
The benefits of ADHD medicine exceed the risks
The benefits of the medicine exceed the risks when children and young people with activity and attention problems - ADHD (attention deficit hyperactivity disorder) - are given medicine containing the substance methylphenidate.
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23 February 2009 /Side effects and trials
The European Medicines Agency (EMEA) continues to recommend vaccination with Gardasil®
EMEA has reviewed two cases from Spain, where two girls experienced prolonged and severe seizures with loss of consciusness after they had been vaccinated with the cervical cancer vaccine Gardasil®.
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20 February 2009 /Side effects and trials
The European Medicines Agency (EMEA) recommends the European Commission to suspend the marketing authorisation of Raptiva®
The Committee for Medicinal Products for Human Use (CHMP) under EMEA has concluded that the benefit of the medicinal product Raptiva® (efalizumab) for patients with moderate plaque psoriasis can no longer justify the risk of a number of serious adverse reactions, first and foremost progressive multifocal leukoencephalopathy (PML)
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16 February 2009 /Side effects and trials
Atopic dermatitis and vaccination with Gardasil®
The HPV vaccine Gardasil® provides protection for cervical cancer. The vaccine has been on the Danish market since 2006. As of 1 January 2009, the vaccine is included in the Danish childhood immunisation programme as an offer for all 12-year-old girls.
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03 February 2009 /Side effects and trials
The MRI contrast agent Dotarem®
Dotarem® is a gadolinium-containing contrast agent used in connection with MRI scanning. Gadolinium-containing contrast agents must be used with extreme care when scanning patients with renal impairment because these patients excrete the contrast agent significantly slower than patients with normal renal function.
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16 January 2009 /Side effects and trials
The use of Omniscan for kidney patients
In February 2007, the Danish Medicines Agency changed its recommendations concerning the use of Omniscan for kidney patients due to a strong suspicion that the contrast medium may cause the serious adverse reaction: Nephrogenic Systemic Fibrosis
