Notice on alienation of medicines batches on the Romanian market
04.02.2015
The Agency for Medicinal Products and Medical Devices (HALMED) has been notified on alienation of certain medicines batches from a hospital pharmacy in Romania. The notice concerns the following medicines:
- Avastin 25 mg/ml, vial 4 ml, batch B7110B01 (expiry date: 11/2015) and B8000B02 (expiry date: 4/2016)
- Avastin 25 mg/ml, vial 16 ml, batch B7031B03 (expiry date: 2/2016) and B7050B06 (expiry date: 6/2’16)
- Herceptin 150 mg, batch H4450B03 (expiry date: 5/2018)
- Nivestim 30MU/0.5 ml, batch 2861123B (expiry date; 31/03/2016)
- Torisel 25 mg/ml, batch AJ64/92 (expiry date: 30/04/2017)
Wholesalers are advised that in case of receipt of some of these batches additionally verify whether the product is purchased from a legal supply chain.
The affected batches have never been placed on the Croatian market.
Even though these batches have not been distributed in the republic of Croatia, all healthcare professionals are advised to pay special attention when handling and administering of these medicines. In case of any suspected counterfeit medicinal product, a report should be sent to HALMED by e-mail: krivotvorine@halmed.hr.
HALMED has never received any suspected counterfeit of these medicines, nor quality defect report or suspected adverse reaction indicating a counterfeit product. HALMED will continue to monitor from the close the safe use of these medicines and promptly make publically available any new information.
