Vivanza

Withdrawn

This medicine's authorisation has been withdrawn

vardenafil

Overview

The marketing authorisation for Vivanza has been withdrawn at the request of the marketing-authorisation holder.

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

  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

AdoptedReference Number: EMA/411229/2013

Initial marketing authorisation documents

Vivanza : EPAR - Scientific Discussion

Vivanza : EPAR - Procedural steps taken before authorisation