Sildenafil Teva

RSS

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 Sildenafil Teva. 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 Sildenafil Teva.

This EPAR was last updated on 30/10/2019

Authorisation details

Product details
Name
Sildenafil Teva
Agency product number
EMEA/H/C/001073
Active substance
sildenafil
International non-proprietary name (INN) or common name
sildenafil
Therapeutic area (MeSH)
Erectile Dysfunction
Anatomical therapeutic chemical (ATC) code
G04BE03
GenericGeneric

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
Teva B.V. 
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
30/11/2009
Contact address

Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Product information

16/08/2019 Sildenafil Teva - EMEA/H/C/001073 - N/0036

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

Drugs used in erectile dysfunction

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 Teva to be effective, sexual stimulation is required.

Assessment history

How useful was this page?

Add your rating