Press Release: European Medicines Agency agrees to precautionary recall of Advagraf 0.5 mg capsule batches

Author (Corporate)
Series Title
Series Details EMA/CHMP/840800/2011 (20.10.11)
Publication Date 20/10/2011
Content Type

The European Medicines Agency (EMA), on 20 October 2011, announced that it had agreed to the immediate recall of some batches of 0.5 mg prolonged-release hard capsules of Advagraf (tacrolimus) from pharmacies and wholesalers across the European Union. This followed detection of more active substance than expected being released from the capsules.

Advagraf is used to prevent organ rejection in adults who have had a kidney or liver transplant or to treat organ rejection when other medicines have not worked.

Source Link http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/10/news_detail_001367.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Press Release: EMA/CHMP/840800/2011 (20.10.11) http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/10/WC500116863.pdf

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