Replacement | Medicines | 05/05/2011

The marketing authorization holder informed its supplied customers by letter dated May 3, 2011, that an atypically elevated value of a known, characterized degradation product was detected in the batches listed above. However, the values are within the specification of the product. In order to prevent an overspecification from occurring within the remaining life of the affected batches, the marketing authorization holder is replacing the affected batches.


Name of the medicinal product 1) Navelbine 10 mg – Infusionskonzentrat
2) Navelbine 50 mg – Infusionskonzentra
Marketing authorisation number(s) 1) 1-20425
2) 1-20428
Marketing authorisation holder Boehringer Ingelheim RCV GmbH & Co KG
Batch number(s) 1) 2P109_A, 1P107
2) 1P506
Classification of the recallIII
BASG reference number INS-640.001-0119

Further inquiry note