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Priligy(TM) (Dapoxetine) Receives First Regulatory Approvals for the Treatment of Premature Ejaculation (PE) in Finland and Sweden
Acording to a public release of Janssen-Cilag EMEA, a division of Janssen Pharmaceutica N. V., Priligy(TM)
(also known as Dapoxetine Hydrochloride) has received marketing authorisation in Finland and Sweden for the on-demand
treatment of premature ejaculation
(PE) in men 18-64 years of age.
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| Medication |
Qty |
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30.000 mg dapoxetine |
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film coated |
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30.000 mg dapoxetine |
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film coated |
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Priligy 60mg
60.000 mg dapoxetine |
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film coated |
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Priligy 60mg
60.000 mg dapoxetine |
6 tablets
film coated |
$174.84 |
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These approvals follow the positive outcome of a decentralised marketing authorisation procedure in seven European Union
countries. Priligy is only available in a few European countries which are Sweden, Austria, Finland, Germany, Spain,
Italy and Portugal. The procedure was finalised in December 2008, and Finland and Sweden are the first countries
worldwide to grant marketing authorisation for this compound. National approvals and licenses in the other five
European countries are expected to follow.
Dapoxetine is not approved yet for marketing in the United States. It has been rejected by the FDA, and it's safe to
say that this is due to a lack of proven benefits versus the risk of potential side effects. Dapoxetine is similar
to a group of anti-depressants considered potentially dangerous for their potentially psychological effects such as
suicidal thoughts and an increased risk of suicide. By consequence, FDA asked for more trials revealing the long
term effects of Dapoxetine use, and it may be a few years before it is approved, if it is approved for sale.
Dapoxetine is marketed and sold under the name Priligy, as Dapoxetine Hydrochloride is actually the generic formula
of the drug.
If approved, Dapoxetine (Priligy) would be the first prescription medication for premature ejaculation and
lasting longer in bed treatment.
Until now, trials of Dapoxetine have included 2,614 men aged 18-77 with premature ejaculation. Those who were
given Dapoxetine in the study reported a noticeable increase in their time before climax as compared with those men
in the study given a placebo. Dapoxetine seems to be an
effective premature ejaculation treatment.
This beneficial effect occurred after the first dose and increased over the study period.
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