The marketing authorisation holder informed its customers on October 22, 2019 that following out-of-specification results during manufacturing below mentioned batches are recalled as a precautionary measure. The quality issues during manufacturing may result in potential loss of sterility, container closure integrity and formation of particles.
|Name of the medicinal product||AVONEX 30 Mikrogramm /0,5 ml Injektionslösung im Fertigpen|
|Marketing authorisation number(s)||EU/1/97/033/005|
|Marketing authorisation holder||Biogen Netherlands B.V.|
|Classification of the recall||1|
|Depth of recall||Pharmacies|
|BASG reference number||INS-640.001-3009|