Expanded indication for Nycomed's TachoSil®

17.02.2009

European Medicines Agency (EMEA) has granted expanded indication

Surgical patch TachoSil® - first and only dual action patch for general tissue sealing


Today Nycomed received an expanded indication for TachoSil®, its innovative surgical patch, from the European Medicines Agency (EMEA). To date, TachoSil was approved for haemostasis (control of bleeding) in surgery. With the new expanded indication, it becomes the first and only dual action patch approved for haemostasis, tissue sealing as well as for suture support in vascular surgery.

TachoSil is the key product in Nycomed's tissue management portfolio and effectively fulfils the market need for a ready-to-use surgical patch, developed to assist surgeons in achieving fast and reliable bleeding control. Now, with the new expanded indication, Nycomed can offer a dual action patch approved for haemostasis, tissue sealing as well as for suture support in vascular surgery.

"With the expansion of TachoSil's indication, Nycomed will bring the benefits of this unique product to surgical teams and those patients undergoing lung or other types of surgery requiring rapid air or body fluid sealing," said Lone Nørgaard Andersson, International Brand Manager at Nycomed.

The new indication was filed with the EMEA in 2008, based on international clinical trial results on lung and cardiovascular surgery. TachoSil is currently available in Europe and Russia/CIS. In the United States, the product will be marketed by Baxter International Inc., while Nycomed will manufacture it and be responsible for the US regulatory filing.

About Nycomed

Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio.

Its R&D is built to be open for partnerships as in-licensing is a cornerstone in the company's growth strategy.

The company employs 12,000 associates worldwide, and its products are available in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS, and Latin America. While the US and Japan are commercialised through best-in-class partners, Nycomed will further strengthen its position in key Asian markets.

Headquartered in Zurich/Switzerland, the company generated in 2007 total sales of € 3,5 billion and an adjusted EBITDA of € 1,2 billion.

For more information visit www.nycomed.com

 

For further information

Media:
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Beatrix Benz,

phone: +41 44 555 1508
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phone: +41 44 555 1501

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Christian B. Seidelin,

phone: +41 44 555 11 04

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