Vizarsin

sildenafil

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This is a summary of the European public assessment report (EPAR) for Vizarsin. 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 Vizarsin.

What is Vizarsin?

Vizarsin is a medicine that contains the active substance sildenafil. It is available as film-coated tablets (25, 50 and 100 mg) and as orodispersible tablets (25, 50 and 100 mg). Orodispersible means that the tablet dissolves in the mouth.

Vizarsin is a ‘generic medicine’. This means that Vizarsin is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Viagra. 

What is Vizarsin used for?

Vizarsin is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Vizarsin to be effective, sexual stimulation is required.

The medicine can only be obtained with a prescription.

How is Vizarsin used?

The recommended dose of Vizarsin is 50 mg taken as needed about one hour before sexual activity. If Vizarsin is taken with food, the onset of activity may be delayed compared with taking Vizarsin without food. The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects. Patients with reduced liver or severely reduced kidney function should start treatment with the 25-mg dose. The maximum recommended dosing frequency is one tablet per day.

How does Vizarsin work?

The active ingredient in Vizarsin, sildenafil, belongs to a group of medicines called phosphodiesterase-type-5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cGMP, Vizarsin restores erectile function. Sexual stimulation is still needed to produce an erection.

How has Vizarsin been studied?

Because Vizarsin is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefit and risk of Vizarsin?

Because Vizarsin is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has Vizarsin been approved?

The CHMP concluded that, in accordance with EU requirements, Vizarsin has been shown to have comparable quality and to be bioequivalent to Viagra. Therefore, the CHMP’s view was that, as for Viagra, the benefit outweighs the identified risk. The Committee recommended that Vizarsin be given marketing authorisation.

Other information about Vizarsin

The European Commission granted a marketing authorisation valid throughout the European Union for Vizarsin on 21 September 2009.

For more information about treatment with Vizarsin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Vizarsin : EPAR - Summary for the public BG = bălgarski 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public ES = español 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public CS = čeština 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public DA = dansk 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public DE = Deutsch 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public ET = eesti keel 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public EL = elliniká 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public EN = English 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public FR = français 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public IT = italiano 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public LV = latviešu valoda 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public LT = lietuvių kalba 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public HU = magyar 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public MT = Malti 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public NL = Nederlands 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public PL = polski 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public PT = português 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public RO = română 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public SK = slovenčina 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public SL = slovenščina 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public FI = suomi 09/10/2009 09/07/2012
Vizarsin : EPAR - Summary for the public SV = svenska 09/10/2009 09/07/2012

This EPAR was last updated on 10/12/2013 .

Authorisation details

Product details

Product details for Vizarsin
NameVizarsin
Agency product numberEMEA/H/C/001076
Active substance

sildenafil

International non-proprietary name (INN) or common name

sildenafil

Therapeutic area Erectile Dysfunction
Anatomical therapeutic chemical (ATC) code G04BE03
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Vizarsin
Marketing-authorisation holder

Krka, d.d., Novo mesto

Revision9
Date of issue of marketing authorisation valid throughout the European Union21/09/2009

Contact address:

Krka, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

Product information

26/11/2013  Vizarsin -EMEA/H/C/001076 -IB/0017

Name Language First published Last updated
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013
Vizarsin : EPAR - Product Information SV = svenska 09/10/2009 10/12/2013

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.


Name Language First published Last updated
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012
Vizarsin : EPAR - All Authorised presentations SV = svenska 09/10/2009 09/07/2012

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 Vizarsin to be effective, sexual stimulation is required.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Vizarsin : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 27/08/2010 10/12/2013
Vizarsin-H-C-1076-X-06 : EPAR - Assessment Report - Extension SV = svenska 09/07/2012  

Initial marketing-authorisation documents

Name Language First published Last updated
Vizarsin : EPAR - Public assessment report SV = svenska 12/10/2009  
Committee for medicinal products for human use, summary of positive opinion for Vizarsin SV = svenska 24/06/2009  

Authorised

This medicine is approved for use in the European Union

More information on Vizarsin