Vivanza

Withdrawn

This medicine's authorisation has been withdrawn

vardenafil

Overview

On 3 February 2022, the European Commission withdrew the marketing authorisation for Vivanza (vardenafil) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Bayer AG, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Vivanza was granted marketing authorisation in the EU on 4 March 2003 for the treatment of erectile dysfunction. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2007.The product had not been marketed in the EU since 2021. 

Vivanza was a duplicate of Levitra, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Levitra. 

The European Public Assessment Report (EPAR) for Vivanza is updated to indicate that the marketing authorisation is no longer valid.

Vivanza : EPAR - Summary for the public

Vivanza : EPAR - Risk-management-plan summary

Product information

Vivanza : EPAR - Product Information

Vivanza : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Vivanza
• Active substance:
  vardenafil
• International non-proprietary name (INN) or common name:
  vardenafil
• Therapeutic area (MeSH):
  Erectile Dysfunction
• Anatomical therapeutic chemical (ATC) code:
  G04BE09

Pharmacotherapeutic group

Urologicals

Therapeutic indication

Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

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

Vivanza is not indicated for use by women.

Authorisation details

• EMA product number:
  EMEA/H/C/000488
• Marketing authorisation holder:
  Bayer AG

  51368 Leverkusen; Germany

• Marketing authorisation issued:
  04/03/2003
• Revision:
  28

Assessment history

Changes since initial authorisation of medicine

Vivanza : EPAR - Procedural steps taken and scientific information after authorisation

Vivanza-H-C-PSUSA-00003098-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/684140/2019

Vivanza-H-C-488-X-43 : EPAR - Assessment Report - Extension

Adopted Reference Number: EMA/411229/2013

Initial marketing authorisation documents

Vivanza : EPAR - Scientific Discussion

Vivanza : EPAR - Procedural steps taken before authorisation