MabThera (Inopha)
Recall
|
Medicines
|
11/09/2014
The parallel distributor informed its supplied customers on 10.09.2014 that the batches originating from Romania had been illegally introduced into the legal distribution chain and that the product may therefore no longer be used. These batches were delivered to Austrian hospitals in parallel distribution by "INOPHA GmbH".
| Name of the medicinal product | 1. MabThera 100 mg Konzentrat zur Herstellung einer Infusionslösung 2. MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung |
|---|---|
| Marketing authorisation number(s) | 1. EU/1/98/067/001 2. EU/1/98/067/002 |
| Marketing authorisation holder | Roche Registration Limited Paralleldistribution: INOPHA GmbH |
| Batch number(s) | 1. MabThera 100 mg: H0121B09, H0122B04, H0124B02 2. MabThera 500 mg: H0579B03, H0625B04, H0631B01, H0662B03 |
| Classification of the recall | 1 |
| BASG reference number | INS - 640.001 - 1212 |
Further inquiry note
Page last modified:
12/07/2022