Velcade 3.5 mg powder for solution for injection

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.

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

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

Marketing authorization dates and numbers

EU/1/04/274/001

Date of first authorization: 26 Apr 2004

Date of latest renewal: 26 Apr 2009

Drugs

Drug
Countries
Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, United States, South Africa