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July 8th, 2008

European Medicines Agency: CHMP, Initial Marketing Authorisation Applications, 24-27 April 2006

Patients were considered responders if they buzz a slimming down in their migraine days of at lowest sufficient 50%. Satisfaction with the utility of treatment among patients in the study was also significantly greater for TOPAMAX compared to placebo. Moreover, a significant and clinically applicable reduction in migraine days was also reported in a group of patients who overused acute medication. Significantly not as markedly of patients treat with TOPAMAX own overused acute medication at the indirect up of the trial compared to patients on placebo (topiramate therapy: baseline 63% of patients, end of trial 28%; placebo baseline: 67% of patients, end of trial 59%).

— Baraclude (entecavir), from Bristol-Myers Squibb Pharma EEIG, for the treatment of habitual hepatitis B. EMEA review began on 18 October 2004, with an active review time of 210 days.

— Nexavar (sorafenib tosylate), from Bayer Healthcare AG, for the treatment of advanced renal cell cancer in patients who personal messed up prior interferon-alpha or interleukin-2 bed analysis or be considered not fitting for such therapy. EMEA review began on 28 September 2005, with an active review time of 177 days. Nexavar be the twenty-sixth waif medicinal merchandise to receive a useful CHMP close.

— RotaTeq (rotavirus vaccine), from Sanofi Pasteur MSD, for the averting of rotavirus gastroenteritis in infant from 6 weeks of age. EMEA review began on 18 May 2005, with an active review time of 190 days.

— Tysabri (natalizumab), from Elan Pharma International Ltd, for the treatment of multiple sclerosis. EMEA review began on 21 June 2004, with an active review time of 176 days.

The CHMP also adopt the original positive opinion on the granting of a conditional marketing authorisation below trial EU rules on conditional approvals that be left impetus at the morning of April 2006: — Sutent (sunitinib malate), from Pfizer Ltd, for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) after breakdown of imatinib mesylate treatment in the red to chafing or intolerance, and advanced and/or metastatic renal cell carcinoma (MRCC) after failure of interferon alfa or interleukin-2 therapy. EMEA review began on 28 September 2005, with an active review time of 177 days.

European Medicines Agency: CHMP, Initial Marketing Authorisation Applications, 24-27 April 2006

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