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CSL Ltd. Regulatory Filings 2016

Feb 28, 2016

17854_rns_2016-02-28_a8533da6-535d-4725-ae24-7b156d0198ae.pdf

Regulatory Filings

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29 February 2016

IDELVION[® ] (rFIX-FP) - CHMP recommendation

CSL Limited (ASX:CSL; USOTC:CSLLY) - CSL today announced that the European Medicines Agency ( EMA ) Committee for Medicinal Products for Human Use ( CHMP ) has recommended granting marketing authorization for IDELVION[®] (Coagulation Factor IX (Recombinant), Albumin Fusion Protein) for patients with haemophilia B. IDELVION[®] is CSL Behring’s long-acting fusion protein, linking recombinant coagulation factor IX with recombinant albumin. IDELVION[®] was designated as an orphan medicinal product in 2010 by the European Commission.

“CHMP’s positive opinion for IDELVION[®] moves us one step closer to bringing this longacting treatment option to haemophilia B patients in Europe,” said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited. “Once approved, IDELVION[®] will provide haemophilia B patients in the European Union with a treatment option with prolonged dosing intervals up to 14 days. These intervals have been achieved while maintaining high levels of factor activity and very low annualized bleeding rates, delivering on our promise to develop and bring to market innovative specialty biotherapies that help patients live full lives.”

About Haemophilia B

Haemophilia B is a congenital bleeding disorder characterized by deficient or defective factor IX. Haemophilia B affects more than 10,000 people throughout Europe according to the European Haemophilia Consortium.

About IDELVION

CSL Behring engineered IDELVION[®] to extend the half-life of recombinant factor IX through fusion with recombinant albumin. CSL Behring selected recombinant albumin as its fusion partner for its coagulation factor proteins due to its long physiological half-life.

IDELVION[®] is approved in Canada and regulatory agencies in the U.S., Australia, Switzerland and Japan are also currently reviewing CSL Behring’s license applications for IDELVION[®] .

About CSL

CSL is a leading global biotherapeutics company with a dynamic portfolio of life-saving innovations, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two

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29 February 2016

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businesses CSL Behring and Seqirus — operates in over 30 countries with more than 16,000 employees. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information, please visit www.csl.com.au.

For further information, please contact:

Investors: Mark Dehring Head of Investor Relations CSL Limited Phone: +613 9389 3407 Email: [email protected]

Media: Sharon McHale Head of Public Affairs CSL Limited Mobile +61 409 978 314 Email: [email protected]

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