Denosumab (investigational product)
Replacement
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Medicines
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02/10/2013
During a routine quality check, a small number of prefilled syringes were found to contain particles consisting mainly of cellulose fibers. The voluntary exchange only affects investigational products with the above batch numbers that were marketed for two clinical trials (Amgen Protocol Nos. 20050209 and 20060289). Amgen has identified those investigational sites that have received investigational products from these batches and informed them of this exchange by letter dated Sept. 19, 2013.
| Name of the medicinal product | Denosumab 60 mg/ml Injektionslösung (Fertigspritze ohne Nadelschutz) |
|---|---|
| Marketing authorisation number(s) | Keine (klinisches Prüfpräparat) |
| Marketing authorisation holder | 1. Sponsor: Amgen Limited EudraCT Number: 2005-005275-15, Sponsor Protocol Number: 20050209 2.Sponsor: Amgen Inc. EudraCT Number: 2007-001041-17 Sponsor Protocol Number: 20060289 Durchführung Austausch: Amgen Europe B.V., NL |
| Batch number(s) | 1. 1041477 (Denosumab 60 mg/ml oder Placebo), 1041478 (Denosumab 60 mg/ml oder Placebo) 2. 1041071 (Denosumab 60 mg/ml) |
| Classification of the recall | 2 |
| BASG reference number | INS-640.001-0902 |
Further inquiry note
Page last modified:
12/07/2022