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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?


To: DaiS who wrote (12640)8/5/1998 7:37:00 AM
From: DaiS  Respond to of 23519
 
EC again - Si puo guidare dopo aver assunto viagra?

eudra.org

On this site you can read the draft EC package leaflet for viagra (follow link and click on EN) and a public statement.

The leaflet warns that "Viagra can cause dizziness and effects on vision. You should be aware of how you react to Viagra before you drive or operate machinery."

Now, the US viagra information on the Pfizer site has no reference to driving. I assume that this is the packet insert information, can someone confirm, this is important.

So in the EC people will be warned about driving on viagra - well the Italians and French are mad drivers!

So will Pfizer now change the US package labelling?

Something else: both the draft package leaflet and the public statement say that,

"You should not use Viagra with any other treatment for erectile dysfunction."

This is stronger than the statement on the Pfizer site for US,

"The safety and efficacy of combinations of VIAGRA with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended."



To: DaiS who wrote (12640)8/5/1998 7:58:00 AM
From: Mkilloran  Read Replies (1) | Respond to of 23519
 
dias....the answer to your question is on yahoo vvus board 14835 from riskman

the process that vivus went thru to get muse in the UK and the filing for all of europe vrs the approach that phizer took with viagra going directly for all of europe.



To: DaiS who wrote (12640)8/5/1998 12:26:00 PM
From: DaiS  Respond to of 23519
 
In fairness, re EC approval strategy, I think my

Conjecture: "Vivus have fucked up in some way"

can in fact be rejected tentatively