Viagra

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sildenafil

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Viagra. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Viagra.

This EPAR was last updated on 12/07/2016

Authorisation details

Product details
Name
Viagra
Agency product number
EMEA/H/C/000202
Active substance
sildenafil
International non-proprietary name (INN) or common name
sildenafil
Therapeutic area (MeSH)
Erectile Dysfunction
Anatomical therapeutic chemical (ATC) code
G04BE03
Publication details
Marketing-authorisation holder
Pfizer Limited
Revision
30
Date of issue of marketing authorisation valid throughout the European Union
13/09/1998
Contact address
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

16/06/2016 Viagra - EMEA/H/C/000202 - N/0093

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

UROLOGICALS

Therapeutic indication

Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

In order for Viagra to be effective, sexual stimulation is required.

Assessment history

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