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31 May 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – May 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 21-23 May 2012.
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29 May 2012 /Side effects and trials
Risk of blood clots associated with hormonal contraceptives
A new major Danish registry study has investigated the risk of blood clots in women using different types of hormonal contraceptives. The study concludes, among other things, that women using a vaginal ring (Nuvaring®) or contraceptive patch (Evra®) have the highest risk of blood clots.
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24 May 2012 /Side effects and trials
European Commission publishes guideline concerning the quality of biological investigational medicinal products in clinical trials
The European Commission has published a guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials.
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23 May 2012 /Side effects and trials
Increased risk of cardiac arrest associated with the use of TCA and SSRI antidepressants
A new Danish study has found an increased risk of cardiac arrest associated with treatment with TCAs (tricyclic antidepressants) or SSRIs (selective serotonin reuptake inhibitors). The study found no association between increased risk of cardiac arrest and the use of SNRI antidepressants (serotonin and norepinephrine reuptake inhibitors) or NaSSA antidepressants (noradrenergic and specific serotonergic antidepressants).
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15 May 2012 /Side effects and trials
Pradaxa – consider age and follow dose recommendations
In March, in collaboration with the Thrombosis Centre in Aalborg, the Danish Health and Medicines Authority published an evaluation of all adverse reaction reports in Danish Pharmacovigilance Update for the period 22 August 2011 up to and including 23 February 2012 in connection with a new indication (prevention of apoplexy in patients with non-valvular atrial fibrillation) for Pradaxa® (dabigatran etexilate). With this announcement, we once more want to call attention to the development in consumption, reported adverse reactions, age and dose recommendations.
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14 May 2012 /Authorisation and supervision
Announcement of time slots for decentralised procedures in 2013
The Danish Health and Medicines Authority announces allocation periods for time slots in 2013 for decentralised procedures (DCP) with Denmark as Reference Member State (RMS).
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10 May 2012 /Side effects and trials
Drug Analysis Prints with data from more than 14,000 side effect reports
In February, the Danish Health and Medicines Authority published the first 14 of approximately 1,000 adverse reactions prints, called Drug Analysis Prints, of suspected adverse drug reactions (ADRs) reported by doctors, patients and relatives. We have now published the rest.
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01 May 2012 /Side effects and trials
Questions and answers from the Clinical Trial Facilitation Group on trial designs and DSUR
The Clinical Trial Facilitation Group (CTFG) has drawn up a Q&A document on specific trial designs and a document on Development Safety Update Report (DSUR). The CTFG was formed in 2004 by the Heads of Medicines Agencies (HMA), one of the purposes being to obtain a more uniform interpretation of the EU regulatory requirements.
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01 May 2012 /Authorisation and supervision
Clarification regarding parallel imported medicines when the directly imported medicinal product has been deregistered
Generally, it is the parallel importer's responsibility to maintain the authorised summary of product characteristics (SPC) and the package leaflet (PL) when the directly imported medicinal product has been deregistered. Therefore any changes to the SPC and PL, including regular updates to the safety information, must be submitted as variation applications by the parallel importer.
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01 May 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – April 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 16-18 April 2012. Among the topics discussed at the meeting were:
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01 May 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – March 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 12-14 March 2012. Among the topics discussed at the meeting were:
