The marketing authorisation for Orlaam has been withdrawn at the request of the marketing authorisation holder.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||
Sipaco Internacional Lda.
|Date of issue of marketing authorisation valid throughout the European Union||
Sipaco Internacional, Lda.
Avenida 5 de Outubro, 267 - 6a dto
11/06/2002 Orlaam - EMEA/H/C/000077 -
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.
ORLAAM is indicated for the substitution maintenance treatment of opiate addiction in adults previously treated with methadone, as part of a comprehensive treatment plan including medical, social and psychological care.
ORLAAM should be administered under the supervision of physicians with experience in addiction treatment and whenever practicable, in centres specialising in the treatment of drug addiction.
ORLAAM is not intended for take home use.