Taluvian

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Withdrawn

This medicine's authorisation has been withdrawn

apomorphine
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 28 May 2001 the European Commission granted a marketing authorisation for the whole European Union to Abott SpA Italy, for Taluvian (apomorphine hydrochloride), indicated for the treatment of erectile dysfunction. Taluvian has been marketed only in Spain. 

On 13 May 2004 the Marketing Authorisation Holder notified the European Commission of its decision to voluntarily withdraw the Marketing Authorisation for Taluvian for commercial reasons. There is still one Community Marketing Authorisation valid throughout the European Union for medicinal products containing apomorphine hydrochloride i.e. Uprima. On 13 July 2004 the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use “Taluvian”. 

Pursuant to this decision the European Public Assessment Report for Taluvian has been removed from this website.

Product information

13/07/2004
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Product details

Name of medicine
Taluvian
Active substance
apomorphine hydrochloride
International non-proprietary name (INN) or common name
apomorphine
Therapeutic area (MeSH)
Erectile Dysfunction
Anatomical therapeutic chemical (ATC) code
G04BE

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 Taluvian to be effective, sexual stimulation is required.

Authorisation details

EMA product number
EMEA/H/C/000386
Marketing authorisation holder
Abbott S.r.l.

Abbott S.p.A.
I-04010 Campoverde di Aprilia
(Latina)
Italy

Marketing authorisation issued
28/05/2001
Withdrawal of marketing authorisation
13/07/2004
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