EMA approves recall of Advagraf 0.5 mg capsules.
M2 PHARMA-October 24, 2011-EMA approves recall of Advagraf 0.5 mg capsules(C)2011 M2 COMMUNICATIONS
24 October 2011 - The European Medicine Agency (EMA) has given the green light to the immediate recall of several batches of 0.5 mg prolonged-release hard capsules of Advagraf (tacrolimus) triggered by the detection of more active substance than expected being released from the capsules.
Although the information collected so far does not show any clinical adverse effects to be caused by the defect, the recall was launched as a precaution because the defect could have resulted in the build-up of slightly higher doses of tacrolimus in the blood of patients taking the affected capsules.
The defect was discovered in a routine test by the company, which holds the marketing authorisation, Astellas (TYO:4503).
The decision is unlikely to affect the overall supply of Advagraf as the recall only affects batches derived from one parent batch of Advagraf 0.5 mg prolonged-release hard capsules.
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