PIL- Bortezomib Accord 2.5 mg/ml solution for injection: Change history
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.
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.
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Changes: (Updated: 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.
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Changes: (Updated: 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.
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Changes: (Updated: 20 Sep 2022)
Initial upload