Overview
The marketing authorisation for Uprima has not been renewed by the marketing authorisation holder and is now withdrawn.
Authorisation details
| Product details | |
|---|---|
| Name |
Uprima
|
| Agency product number |
EMEA/H/C/000327
|
| Active substance |
apomorphine hydrochloride
|
| International non-proprietary name (INN) or common name |
apomorphine
|
| Therapeutic area (MeSH) |
Erectile Dysfunction
|
| Anatomical therapeutic chemical (ATC) code |
G04BE
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Abbott Laboratories Ltd.
|
| Revision |
4
|
| Date of issue of marketing authorisation valid throughout the European Union |
28/05/2001
|
| Contact address |
Queenborough
Kent ME11 5EL United Kingdom |
Product information
29/05/2006 Uprima - EMEA/H/C/000327 -
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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 Uprima to be effective, sexual stimulation is required.