Product Documentation

• View Patient Information Leaflet (PIL- Bortezomib Accord 2.5 mg/ml solution for injection)

  Last updated on this site: 12 Nov 2025

  1. To register the deletion of Accord Healthcare B.V., Utrecht, Winthontlaan 200 3526 KV at

  Utrecht, Netherland as a site responsible for batch release site of the finished product.

  Consequently, the PIL has been updated.

   

  2. To register a change in the name of the site responsible for batch control/testing of the

  finished product from Eurofins Analytical Services Hungary Kft to Eurofins BioPharma

  Product Testing Budapest Kft. The address remains the same at Anonymus u. 6., Budapest,

  1045, Hungary.

   

  3. To register a change in the name of the site responsible for batch control/testing of the

  finished product from PHARMAVALID Ltd to PHARMAVALID Kft. The address remains the

  same at 1136 Budapest, Tátra utca. 27/b, Hungary.

   

  4. To register a change in the name of the site responsible for batch control/testing of the

  finished product from Lab Analysis S.r.l. to Labanalysis Life Science S.r.l. The address

  remains the same at Via Europa 5, Casanova Lonati (Pavia) 27041, Italy.

  View change history
• View Summary of Product Characteristics (SmPC- Bortezomib Accord 2.5 mg/ml solution for injection)

  Last updated on this site: 27 Mar 2025

  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.

  View change history