SmPC- Bortezomib Accord 2.5 mg/ml solution for injection: Change history

1. To update sections 4.6 and 5.3 of the SPC in with the

reference product, VELCADE 1 mg/3.5 mg powder for solution

for injection, EU procedure number:

EMEA/H/C/000539/II/0102, MAH: JANSSEN CILAG

INTERNATIONAL NV, Belgium.

2. To update the ATC Code for Bortezomib Accord 3.5mg/1mg

powder for solution for injection from “L01XX32” to

“L01XG01” as published by WHO. Consequently, section 5.1

of the SPC has been updated.

Additionally, sections 2, 4.8, 5.1, 5.2 and 6.5 of the SPC and

sections 2 and 4 of the leaflet have been updated with editorial

changes in line with reference product.