Navelbine
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 recall | III |
| BASG reference number | INS-640.001-0119 |
Further inquiry note
Page last modified:
12/07/2022