CHAMPIX 0,5 mg + 1 mg Filmtabletten

Recall | Medicines | 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 recall2
Depth of recall Pharmacies
BASG reference number INS-640.001-3550
Safety warnings Link Safety information (DHPC): 211004_Champix.pdf

Further inquiry note