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, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, Singapore, Tunisia, United Kingdom, United States