GLIADEL Implant

Active ingredients: Carmustine

Product name and form

GLIADEL 7.7 MG IMPLANT.

Pharmaceutical Form

Implant.

Off-white to pale yellow flat discoid implant.

Qualitative and quantitative composition

Each implant contains 7.7 mg of carmustine.

For a full list of excipients, see section 6.1.

Active Ingredient
Description

Carmustine is a cell-cycle phase nonspecific antineoplastic agent of the nitrosourea type. As an alkylating agent, it can alkylate reactive sites on nucleoproteins, thus interfering with DNA and RNA synthesis and DNA repair. In addition, carmustine is known to carbamoylate lysine residues on proteins causing irreversible inactivation of enzymes including glutathione reductase.

List of Excipients

Polifeprosan 20

Pack sizes and marketing

GLIADEL Implant is available in a box containing eight implants. Each implant is individually packaged in two aluminium foil laminate sachets.

Marketing authorization holder

MGI PHARMA LIMITED, Holborn Gate, 1st Floor, 330 High Holborn, London,WC1V 7QT, United Kingdom

Marketing authorization dates and numbers

PL 18753/0001

Date of first authorisation: 28/05/1999

Date of last renewal: 10/12/2008

Drugs

Drug
Countries
Australia, Brazil, Spain, France, Hong Kong, Ireland, Singapore, United Kingdom, United States