Note to healthcare professionals about falsified Herceptin in the EU
16.04.2014
The European Medicines Agency (EMA) has been informed about the vials of the cancer medicine Herceptin (trastuzumab). It is thought that these vials have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some Member States.
No affected product has so far been identified at hospital level and there are no reports that any adverse event 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. These include:
- the batch numbers and expiry dates on most vials do not match those on the outer package
- there is liquid present in some vials of Herceptin powder for solution (Herceptin is a white to yellow powder)
- evidence of tampering with rubber stoppers, crimping caps or lids
- the falsified vials are labelled as Italian Herceptin® 150 mg.
The numbers of suspected batches are H411B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H427B01, H4301B09 and H4303B01. None of these batches is present on the Croatian market.
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. In addition, parallel distributers across the EU are being alerted with the above information.
Roche d.o.o., the marketing authorisation holder for the medicine Herceptin 150 mg powder for concentrate for solution for infusion in the Republic of Croatia has committed itself to send a letter to healthcare professionals informing them about it.
According to the current available information, it is not expected that these problems should cause shortage of the medicine for oncologic patients.
In case of any suspected vial of Herceptin, it is necessary to report it to HALMED by e-mail at: krivotvorine@halmed.hr
More about the medicine
Herceptine is an anticancer medicine which is used to treat patients with breast cancer as well as metastatic gastric (stomach) cancer. It is mainly used in hospitals. Herceptin contains the active substance trastuzumab and is available as a 150 mg powder to be made up into a solution for intravenous infusion or as a solution for subcutaneous injection. Only the intravenous formulation appears to be affected.
