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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly)
PFE 25.81-0.3%Nov 13 3:59 PM EST

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To: Anthony Wong who wrote (798)9/15/1998 9:24:00 AM
From: Anthony Wong  Read Replies (1) of 1722
 
BBC: Europe says yes to Viagra
Tuesday, September 15, 1998 Published at 09:58 GMT 10:58 UK

The top-selling anti-impotence drug
Viagra has been the go-ahead for
immediate sale in the European
Union.

The EU's Industry Commissioner Martin Bangemann
signed authorisation for the drug on Tuesday morning,
but said the drug should only be available on
prescription.

The signature was part of a six-month approval process,
which included a scientific assessment by the European
Agency for the Evaluation of Medicinal Products and
clearance from its committee of experts and a standing
committee of representatives from all 15 member states.

However, it is unclear how many governments will agree
to pay for Viagra.

The UK has decided to ban the prescription of Viagra on
the NHS until it can decide on how to ration the drug,
which could cost up to œ100m.

Safe

Other governments may adopt similar positions, but
Pfizer says the UK is the only one so far to announce a
ban.

Each member state has to decide for itself what it will do
about the drug.

Patrick De Boyser of the European
Commission said the drug had been
found to be safe and effective.

He stressed: "It is a medical product
treating a condition, erectile dysfunction."

However, he added that demand for the drug was likely
to be high across Europe and there were "serious
concerns" in several countries about funding the cost of
it.

The EU's body of pharmaceutical experts - the EMEA -
cleared the way for approval of Viagra in August when it
voted to approve a European marketing licence for the
revolutionary drug.

Best-selling drug

Viagra has become the fastest-selling new medicine
since its launch in the US in April.

However, over 100 deaths
around the world are being
investigated in connection
with the drug.

In the US, most of the people who have died are thought
to be elderly people with heart problems and over two
million people have taken the drug without problems.

The EU says Viagra should not be prescribed for
women, people under 18 and those with heart problems.
It recommends that Pfizer warn of the drug's possible
side effects, inlcluding headaches and painful, prolonged
erections.

Pfizer, which plans to have the drug available for sale in
the next two to three weeks, already warns that Viagra
should not be taken in conjunction with nitrate-based
drugs as it could lower blood pressure to dangerous
levels.

The EU will monitor Viagra for five years and, if demand
subsides, it could be made available over the counter.

news.bbc.co.uk
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