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Counterfeits of the medicinal product Xeplion® 150 mg extended-release suspension for injection (batches GFB4D00_BG-RO and GEB3Z00_BG-RO) have reached the German market (including amendments of 2 August 2017, 28 July 2017 and 26 July 2017)

Date 2017.08.02
Active substance paliperidon

Amendment of 2 August 2017
The Federal Institute for Drugs and Medical Devices (BfArM) has received new information on a further batch concerned in the case of counterfeits of the medicinal product Xeplion 150 mg extended-release suspension for injection (active substance: paliperidone) by Janssen-Cilag. The presentation of this batch is likewise Romanian/Bulgarian. The batch designation is GIB3200 (expiration date 09/2018), it actually exists and was found at the parallel distributors FD Pharma GmbH in Baden-Wuerttemberg and Abacus Medicine A/S in Denmark.

Amendment of 28 July 2017
The Federal Institute for Drugs and Medical Devices (BfArM) has received information on two further parallel distributors concerned in the case of counterfeits of the medicinal product Xeplion 150 mg extended-release suspension for injection (active substance: paliperidone) by Janssen-Cilag. The companies concerned are CC Pharma GmbH in Rhineland-Palatinate and European Pharma B.V. in The Netherlands. In both cases, this regards the actually existing batch designation GEB3Z00.

Amendment of 26 July 2017
The Federal Institute for Drugs and Medical Devices (BfArM) has received information on a further batch concerned in the case of counterfeits of the medicinal product Xeplion 150 mg extended-release suspension for injection (active substance: paliperidone) by Janssen-Cilag. This regards the batch designation GGB2500 (expiration date 06/2018) which is an actually existing batch and was found at the parallel distributor EuroPharma in Denmark. The presentation of the medicinal product is Romanian/Bulgarian.

Homepage information of 25 July 2017
The Federal Institute for Drugs and Medical Devices (BfArM) is issuing information on counterfeits of the medicinal product Xeplion 150 mg extended-release suspension for injection (active substance: paliperidone) by Janssen-Cilag that have been found in Germany at several parallel distributors. The medicinal product contains the active substance paliperidone and is used as an antipsychotic agent for treatment of schizophrenia.

risk information - full text (available in German only)