Dear Healthcare Professional Letter on falsified medicines labelled as Herceptin 150 mg, powder for concentrate for solution for infusion (trastuzumab)
24.04.2014
Following to the Note to healthcare professionals about falsified Herceptin in the EU and Information on counterfeited Herceptin, Alimta and Remicade on the EU market, Roche d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals, The letter contains the updated information on falsified medicines labelled as Herceptin 150 mg powder for concentrate for solution for infusion (trastuzumab) in the EU as well as instructions for visual inspection of vials before preparation and administration of medicines.
Summary
- Falsified medicines initialy labelled as "Italian Herceptin” 150 mg vials have been found in the UK, Finland, Germany, Austria and Sweden. Some vials and boxes originally labelled as "Italian Herceptin” may have been re-labelled and re-packaged in the local language.
- Suspected vials and original boxes contain original batch numbers from Roche, but numbers on vials and boxes in some cases maybe do not match. In addition some vials may contain liquid instead of powder or have evidence of tampering with the rubber stoppers, crimping caps or lids.
- So far, 31 batches have been considered as suspected and/or falsification has been identified. The following batch numbers are affected: H4105B01, H4136B02, H4143B01, H4150B01, H4152B04, H4171B01, H4168B02, H4169B01, H4179B02, H4180B01, H4184B02, H4194B01, H4195B01, H4196B01, H4261B01, H4263B02, H4271B01, H4279B01, H4284B04, H4293B01, H4303B01, H4301B09, H4311B07, H4319B02, H4324B03, H4329B01, N1001B01, N1001B01, N1002B02, N1002B03, N1010B02.
- These batches have been recalled from the Austrian, Finish, Swedish and German market. The affected batches vary from country to country and it is therefore necessary to view the HALMED webpages where the recent official information will be published.
- These batches have not been imported or placed on the Croatian market through legal supply chains.
- It is not likely that the recall will cause shortage of medicine for patients, hence only the product packed for Italy and offered for sale out of Italy has been recalled.
- Falsified medicines must not be used as they are not considered neither safe, nor efficient.
- If there is a concern that a medicine might have been falsified, or its authenticity may not be confirmed, as well as in the case that some patient might have taken a falsified medicine, it is necessary to report it immediately to HALMED.
- HALMED is monitoring the situation closely and Roche is undertaking relevant measures in order to assist in the investigation for search of the source of falsified medicine.
Here you may view the Dear Healthcare Professional Letter.
So far, HALMED has not received any suspected report to this falsified medicine, or report to quality defect or suspected adverse reaction which would raise a concern on falsified medicine. HALMED will monitor the safe use of Herceptin and provide promptly the newest information to the public.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
