Withdrawn
This medicine is now withdrawn from use in the European Union.
Overview
The marketing authorisation for Opulis has been withdrawn at the request of the marketing authorisation holder.
This EPAR was last updated on 19/05/2004
Authorisation details
| Product details | |
|---|---|
| Name |
Opulis
|
| Agency product number |
EMEA/H/C/000311
|
| Active substance |
desloratadine
|
| International non-proprietary name (INN) or common name |
desloratadine
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
R06AX27
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Schering-Plough Europe
|
| Revision |
0
|
| Date of issue of marketing authorisation valid throughout the European Union |
15/01/2001
|
| Contact address |
SP Europe
Rue de Stalle, 73 B-1180 Bruxelles Belgium |
Product information
10/03/2004 Opulis - EMEA/H/C/000311 -
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
Pharmacotherapeutic group
Antihistamines for systemic use
Therapeutic indication
Therapeutic indication
Opulis is indicated for the relief of symptoms associated with:
- allergic rhinitis (see section 5.1)
- urticaria (see section 5.1)