Table of contents
The marketing authorisation for Opulis has been withdrawn at the request of the marketing authorisation holder.
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
Rue de Stalle, 73
10/03/2004 Opulis - EMEA/H/C/000311 -
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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).
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Antihistamines for systemic use
Opulis is indicated for the relief of symptoms associated with:
- allergic rhinitis (see section 5.1)
- urticaria (see section 5.1)