Patrex

Withdrawn

This medicine's authorisation has been withdrawn

sildenafil

Overview

On 15 September 1998, the European Commission granted a Marketing Authorisation for the whole European Union to Roerig Farmaceutici Italiana S.p.A, for the medicinal product Patrex (sildenafil), indicated for the treatment of erectile dysfunction. The Marketing Authorisation was subsequently transferred to Pfizer Limited on 23 February 2001. Patrex was never marketed anywhere in the European Union. 

The Marketing Authorisation Holder did not apply to renew the Marketing Authorisation and consequently on 15 September 2003 the 5-year Marketing Authorisation for Patrex expired. 

It should be noted that there is still one Community Marketing Authorisation valid throughout the European Union for sildenafil i.e.Viagra. 

Pursuant to the expiring of the Community Marketing Authorisation the European Public Assessment Report for Patrex has been removed from this website.

Product information

Product details

• Name of medicine:
  Patrex
• Active substance:
  sildenafil
• International non-proprietary name (INN) or common name:
  sildenafil
• Therapeutic area (MeSH):
  Erectile Dysfunction
• Anatomical therapeutic chemical (ATC) code:
  G04BE03

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 Patrex to be effective, sexual stimulation is required. Patrex is not indicated for use by women.

Authorisation details

• EMA product number:
  EMEA/H/C/000204
• Marketing authorisation holder:
  Pfizer Limited

  Ramsgate Road; Sandwich; Kent; CT13 9NJ; United Kingdom

• Marketing authorisation issued:
  15/09/1998
• Withdrawal of marketing authorisation:
  15/09/2003
• Revision:
  4