PHELINUN 200 mg Pulver und Lösungsmittel für ein Konzentrat zur Herstellung einer Infusionslösung New
Recall
|
Medicines
|
22/12/2025
The distribution partner informed its customers on December 22, 2025, that the information stated on the label is not consistent with the labelling of the active substance content and is mutually exclusive. To prevent any potential risk to patients resulting from incorrect dosing, the two affected batches are being recalled.
The medicinal product is authorised in Poland and placed on the market in Austria under the Austrian Act on the Import of Medicinal Products.
| Name of the medicinal product | PHELINUN 200 mg Pulver und Lösungsmittel für ein Konzentrat zur Herstellung einer Infusionslösung |
|---|---|
| Marketing authorisation number(s) | EU/1/20/1487/002 |
| Marketing authorisation holder | Adienne S.r.l. |
| Distributor | Stelopharm GmbH |
| Batch number(s) | Batch, Expiry Date 24P012, 03/2026 24P005, 12/2025 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-5450 |
Further inquiry note
Page last modified:
22/12/2025