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 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