The European Medicines Agency (EMA) has been informed that vials of the cancer medicine Herceptin (trastuzumab), thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries. This is currently being investigated by Member State authorities and updates will be provided as more information becomes available. Italian law enforcement authorities are currently investigating the theft and are looking at whether other medicines may also be affected.

No affected product has so far been identified at hospital level and there are no reports that any harm has come to patients in relation to the falsified medicine and authorities are working to avoid this.

Healthcare professionals across the European Union (EU) are being alerted to the falsified Herceptin vials and are being provided with information on signs seen so far that may indicate a vial is not genuine.

The numbers of the Herceptin batches known to be affected are H4311B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H4271B01, H4301B09 and H4303B01.

Although only a small number of vials is thought to be affected, the marketing authorisation holder for Herceptin, as a precautionary measure, is recalling vials suspected of having being falsified.

For more information please refer to the full press release, available by clicking here.