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AstraZeneca Completes Mutual Recognition Procedure for new Paediatric Indication for Symbicort. Turbuhaler. in the European Union.

Release issued 9th July 2002

AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) for the use of Symbicort. Turbuhaler. as a maintenance treatment for asthma in children (age 6-11 years) in the European Union (EU), Iceland and Norway.

Symbicort is the ideal combination product, containing two very effective and well-established agents - it is the only asthma medication that enables patients to adjust the dose, depending on the severity of their symptoms, without changing inhalers. Therefore, patients can use fewer inhalers, which should improve patient adherence to treatment, said Dr Colin Reddrop, Vice President and Head of the Respiratory and Inflammation Therapy Area, AstraZeneca. Our research shows that patients want to take fewer treatments and use less inhalers. We believe that Symbicort now offers young asthma patients a simple, easy to use treatment that delivers both their bronchodilator and inhaled corticosteroid in one inhaler.

Symbicort, a dry powder inhaler that contains the corticosteroid budesonide and the rapid-acting, long-lasting bronchodilator formoterol, is already successfully used for the treatment of asthma in adults and adolescents. The presence of budesonide and formoterol in the same inhaler has been shown to be highly effective in the treatment of asthma, simultaneously treating the underlying inflammation and symptoms. It allows patients to quickly and effectively gain and maintain control of their asthma at an overall lower steroid dose, and the dose can be adjusted without changing inhalers which provides greater ease of use and flexibility. Symbicort, meets both patients, parents and carers need for a simple asthma therapy, and accommodates the variable nature of the disease.

The recommended starting dose for Symbicort is two inhalations, twice daily with the possibility to reduce the dose, which can include once daily dosing, when good asthma control has been achieved. In the long-term management of asthma, the dose of Symbicort can therefore be adjusted to the individual patients need.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products

The latest news about Symbicort is always easy to find at:

www.symbicort-newscentre.com/

(http://www.symbicort-newscentre.com/)

Note to News Editors:

* European Union countries include Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom.

* Asthma is a chronic inflammatory condition of the airways characterised by reversible airway obstruction. It is a variable condition that can change both daily and seasonally.

* Asthma is the most common chronic childhood illness.

* Up to 25 percent of childhood asthma patients may outgrow the disease, however it is likely to reoccur 10-15 years later.

* Many asthma patients require maintenance treatment with an inhaled corticosteroid, which suppresses the underlying airway inflammation, and a bronchodilator, which relaxes the smooth muscle of the airways.

* Use of a fixed combination of the inhaled corticosteroid budesonide and the rapid-acting, long-lasting bronchodilator formoterol, has shown beneficial in the treatment of asthma. The landmark study FACET showed that a daily dose of 200 mg budesonide, when used together with formoterol, reduces the rate of severe asthma attacks in adult patients with 26 percent compared to a 200 mg dose of budesonide alone.

*Symbicort and Turbuhaler are trademarks of the AstraZeneca group of companies

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