Zebra, Ck out this Viagra article on European approval, some new spins.
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<<Tuesday June 2, 8:15 am Eastern Time
EU confirms "positive opinion" on Viagra
BRUSSELS, June 2 (Reuters) - The European Union's medicines agency confirmed on Monday that its scientific advisory committee had recommended that Pfizer Inc's (PFE - news) impotence treatment Viagra be marketed in Europe.
The London-based European Agency for the Evaluation of Medicinal Products said the European Commission would make the final decision after consulting the 15 EU countries -- a process that normally takes three months.
Pfizer announced last week that the panel, the Committee for Proprietary Medicinal Products, had adopted a ''positive opinion'' on Viagra.
Viagra won approval from U.S. regulators two months ago and quickly became one of the biggest-selling drugs in history.
Six deaths have been reported in the United States, but Pfizer said they were attributed either to cardiovascular events associated with sexual activity in older men or a combination of Viagra and nitrates.
The EU medicines agency said in a statement that it was responding to applications to market Viagra from Pfizer Limited UK and Roerig Farmaceutici SpA, both Pfizer subsidiaries.
It said it had considered the latest safety data available from patients in the United States. However, it said that until the EU gave the final go-ahead, it wanted the companies to provide frequent updates, ''including comprehensive reports of adverse reactions.''
The agency said Viagra's active substance, sildenafil citrate, should not be prescribed to patients who are taking nitrates, have recently had a stroke or heart attack or suffer from low blood pressure, severe heart or liver problems or certain inherited eye diseases.
It added that it should not be used by women.>>
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