Helixate NexGen
Recall
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Medicines
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10/08/2016
CSL Behring as distributor of the product Helixate®NexGen has, in coordination with the marketing authorization holder Bayer Pharma AG, informed its supplied customers by letter dated August 8, 2016, that above mentioned batches of Helixate®NexGen are recalled. Stability data for these batches indicated a faster than usual decline in potency. Batches no longer meeting the potency specification are being recalled.
| Name of the medicinal product | Helixate NexGen 2000 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
|---|---|
| Marketing authorisation number(s) | EU/1/00/144/004 |
| Marketing authorisation holder | Bayer Pharma AG |
| Batch number(s) | 270PWG7C, 270R977C, 270RW8TE |
| BASG reference number | INS-640.001-1804 |
Further inquiry note
Page last modified:
12/07/2022