Share
News
-
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).
-
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).
-
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.
-
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
-
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.
-
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).
-
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.
-
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.
-
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)
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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®.
-
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).
-
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.
