Information on counterfeited Herceptin, Alimta and Remicade on the EU market
18.04.2014
Following to the Note to healthcare professionals about falsified Herceptin in the EU, issued on 16 April 2014, HALMED informs hereby that, apart from Herceptin, the suspected counterfeited medicines in the EU are also linked to vials of Alimta (pemetrexed) and Remicade (infliximab) that have been reported as stolen in Italy.
In addition to Herceptin batch numbers H4311B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H4271B01, H4301B09 and H4303B01, the following batch numbers are now also confirmed to be concerned: H4143B01, H4293B01, H4180B01, N1010B02, H4105B01, H4136B02, H4150B01, H4152B04, H4168B02, H4169B01, H4171B01, H4179B02, H4184B01, H4185B02, H4194B01, H4195B01, H4261B01, H4263B02, H4279B01, N1001B01, N1002B02 and N1002B03.For Alimta, the following batch numbers are known to be concerned: C134092E, C021161E and C160908C and for Remicade batch numbers 3RMA66304, 3RMA67102, 3RMA68106 and 3RMA67602.
Neither of these batches has been found on the Croatian market.
National competent authorities are working rapidly to identify all concerned batches and put in place appropriate measures to protect the health of EU patients. In parallel to the investigations, all vials suspected of being affected are being recalled from the EU market. In addition, Member States authorities are considering temporary measures including quarantine of suspected products or restriction of parallel distribution of the concerned products.
Only a small number of vials of the three medicines are thought to be affected and so far there are no reports that any harm has come to patients in relation to the falsified medicines. Also, no evidence has been identified of any tempered vials of Alimta or Remicade being distributed. According to the current information, it is not expected that the precautionary actions will result in shortage of medicines for patients.
Healthcare professionals are remonded to pay extra attention when handling or administering any of the concerned medicines. Any suspicion of tampering or question of authenticity should be reported immediately to HALMED at: krivotvorine@halmed.hr.
HALMED is monitoring the situation closely and will provide updates as appropriate.
More about the medicines
Herceptin is an anticancer medicine which is used to treat patients with breast cancer as well as metastatic gastric 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.
Alimta is given to treat lung cancer. It is given under the supervision of a doctor who is qualified in the use of chemotherapy. Alimta is a powder that is made up into a solution for infusion. It contains the active substance pemetrexed.
Remicade is an anti-inflammatory medicine, used to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. It contains the active substance infliximab. Remicade is a powder that is made up into a solution for infusion and is administered under the supervision and monitoring of a specialised doctor.
