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Velcade 3.5 mg powder for solution for injection (2012)

Active ingredients: Bortezomib

Product Name and Form

VELCADE 3.5 mg powder for solution for injection.

Pharmaceutical form

Powder for solution for injection.

White to off-white cake or powder.

Qualitative and Quantitative Composition

Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).

After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.

After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Bortezomib

Bortezomib is a proteasome inhibitor. It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells. Inhibition of the 26S proteasome prevents this targeted proteolysis and affects multiple signalling cascades within the cell, ultimately resulting in cancer cell death.

List of excipients

Mannitol (E 421)
Nitrogen

Pack sizes and Marketing

Type 1 glass 10 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a royal blue cap containing 3.5 mg bortezomib.

The vial is contained in a transparent blister pack consisting of a tray with a lid. Each pack contains 1 single-use vial.

Marketing authorization holder
Authorization dates

JANSSEN-CILAG INTERNATIONAL NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Date of first authorization: 26 Apr 2004

Date of latest renewal: 26 Apr 2009

Marketing authorization number:

EU/1/04/274/001