Uprima
Withdrawn
This medicine's authorisation has been withdrawn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 Abbott Laboratories Limited, for Uprima (apomorphine hydrochloride), indicated for the treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. Uprima was marketed in Ireland, UK, Spain, France, Sweden and Norway.
The Marketing Authorisation Holder did not apply to renew the Marketing Authorisation for commercial reasons and consequently on 28 May 2006 the 5-year Marketing Authorisation for Uprima expired.
Following the expiring of the Community Marketing Authorisation the European Public Assessment Report for Uprima has been removed from this website.
Product information
29/05/2006
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
- Uprima
- 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
UrologicalsTherapeutic 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 Uprima to be effective, sexual stimulation is required.
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