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European Union Approves New Indications for Naropin (Ropivacaine), Local Anaesthetic SODERTALJE, SWEDEN -- December 17, 2003 -- AstraZeneca announced today that its long-acting local anaesthetic Naropin® (ropivacaine) was recommended for approval in all EU member states for a new clinical indication as a post-operative pain relief using continuous peripheral nerve block techniques following surgery. "This new indication extends the use of Naropin from surgery into pain management in the post operative period for a large number of additional surgical procedures such as those involving the shoulders, arms and legs," commented Thomas Engberg, Global Brand Director for Zomig/Anaesthesia. "Physicians will now be able to use Naropin, a proven safe and high quality anaesthetic, as a continuous peripheral nerve block during the most painful period after surgery where Naropin provides excellent pain relief for their patients." In clinical studies of peripheral nerve blocks, Naropin (2.0 mg/ml) was shown to provide adequate analgesia for 48 hours after surgery and was well tolerated. Naropin is currently approved for epidural anaesthesia during surgery and post-operative pain relief, pain relief in childbirth, Caesarean section, local infiltration anaesthesia and for surgery using peripheral nerve block techniques. The Netherlands acted as the Reference Member State in the Mutual Recognition procedure for European approval and the medication has already received approval for this new indication in Finland, Sweden Australia, Mexico, New Zealand, Switzerland, the Czech Republic, and Turkey. It is recommended for approval in South Africa. Naropin is the latest addition to the AstraZeneca portfolio of anaesthetics, and its sales has increased by 34% during the first 10 months of 2003, to over $84 million. AstraZeneca is the global leader of the worldwide anaesthesia market with a total market share of 32%. Other AstraZeneca anaesthesia products include the IV anaesthetic, Diprivan®, the topical anaesthetic cream, EMLA®, and the local anaesthetics Xylocaine®, Marcaine®, Carbocaine®, and Citanest®. Total sales of the Anaesthesia portfolio during the first 10 months was $780 million. 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 $17.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index. SOURCE: Shire Health International E-mail this page to a friend or colleague! To print, use this version