Sildenafil Actavis

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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). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 04/12/2018

Authorisation details

Product details
Name
Sildenafil Actavis
Agency product number
EMEA/H/C/001090
Active substance
sildenafil
International non-proprietary name (INN) or common name
sildenafil
Therapeutic area (MeSH)
Erectile Dysfunction
Anatomical therapeutic chemical (ATC) code
G04BE03
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Actavis Group PTC ehf
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
10/12/2009
Contact address
Reykjavíkurvegur 76 - 78
IS-220 Hafnarfjörður
Iceland

Product information

14/11/2018 Sildenafil Actavis - EMEA/H/C/001090 - N/0019

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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 Sildenafil Actavis to be effective, sexual stimulation is required.

Assessment history

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