CSL Ltd. — Regulatory Filings 2002

Dec 9, 2002

AUSTRALIAN STOCK EXCHANGE CSL000114

ASX ANNOUNCEMENT 10 DECEMBER 2002

CSL ADVISES FDA ACCEPTANCE FOR REVIEW OF ZLB'S 12% LIQUID IVIG AND Rh(D) IMMUNOGLOBULIN

CSL Limited today advised that its US subsidiary, ZLB Bioplasma Inc, has announced that the US Food and Drug Administration (FDA) has accepted for review ZLB Bioplasma AG's (CSL's Swiss subsidiary) supplemental biologics licence application (BLA) for a 12% liquid formulation of Immune Globulin Intravenous (Human) (IVIG). The 12% liquid formulation has been designed to meet the needs of the chronic healthcare market and will provide a further option for healthcare professionals to meet the needs of their patients.

This announcement follows advice last week from the FDA that it had also accepted for review ZLB's Rh(D) Immune Globulin. Rh(D) Immune Globulin is a plasma derived product composed of Anti-D immunoglobulin, with a primary indication for the prevention of haemolytic disease of the newborn (HDN), a serious and sometimes fatal disorder in which antibodies produced by pregnant Rh negative women attack the red blood cells of the Rh positive foetus or newborn. ZLB's high capacity plant in Berne, Switzerland, uses a proprietary chromatography process and two viral inactivation and removal steps including nanofiltration to generate highly pure Anti-D immune globulin from the plasma of hyper immune donors. The product has been sold in Switzerland as Rhophylac® since 1996 and was introduced in the European markets in 2001.

Subject to the FDA's favourable review of the BLA for 12% Liquid IVIG and Rh(D) Immune Globulin, CSL anticipates that both products should be available to US patients by 2004. However, this announcement does not mean that a licence has been issued nor does it represent any evaluation of the adequacy of the data submitted with the application.

ZLB's US products, made from plasma collected from US donors, are manufactured by ZLB Bioplasma AG, at its FDA-licensed facility in Bern, Switzerland. ZLB Bioplasma AG is a wholly owned subsidiary of CSL Limited, which acquired the business from the Swiss Red Cross in August 2000.

For further information please contact:

Mr Tony Cipa Finance Director CSL Limited Ph: +61 3 9389 1601

Mr Peter Turner President ZLB Bioplasma AG $Ph:$ +41 31 344 4444