OPDIVO 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung (parallel distribution Orifarm GmbH)
Recall
|
Medicines
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04/04/2024
The parallel distributor and marketing authorisation holder informed its customers on April 03, 2024, that some vials have a defective closure of the crimp cap. The sterility cannot be guaranteed. Therefore, these batches are being recalled as a precautionary measure.
| Name of the medicinal product | OPDIVO 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung |
|---|---|
| Marketing authorisation number(s) | EU/1/15/1014/001-004-P3 |
| CIP code | 4464274 |
| Marketing authorisation holder | Orifarm GmbH |
| Batch number(s) | 8053061 8053059 8053075 |
| Expiry date | 12/31/2025 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-4703 |
Further inquiry note
Page last modified:
10/04/2024