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.

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.

Announcement of time slots for decentralised procedures in 2013

The Danish Health and Medicines Authority is closed on Ascension Day and Friday 18 May

Questions and answers from the Clinical Trial Facilitation Group on trial designs and DSUR