CHAMPIX 0,5 mg + 1 mg Filmtabletten
Recall
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Medicines
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09/07/2021
The marketing authorisation holder informed its customers on July 09, 2021 that due to the risk of exceeding the permitted daily exposure levels for a nitrosamine derivative of the active substance, a recall of the mentioned batches will be carried out as a precautionary measure.
| Name of the medicinal product | CHAMPIX 0,5 mg + 1 mg Filmtabletten |
|---|---|
| Marketing authorisation number(s) | EU/1/06/360/023 |
| CIP code | 3525542 |
| Marketing authorisation holder | Pfizer Europe MA EEIG |
| Distributor | Pfizer Corporation Austria Gesellschaft m.b.H. |
| Batch number(s) | 1. 00019061 2. 00020462 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-3550 |
| Safety warnings Link | Safety information (DHPC): 211004_Champix.pdf |
Further inquiry note
Page last modified:
09/07/2021