Overview
The marketing authorisation for Orlaam has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Orlaam
|
| Agency product number |
EMEA/H/C/000077
|
| Active substance |
levacetylmethadol
|
| International non-proprietary name (INN) or common name |
levacetylmethadol
|
| Therapeutic area (MeSH) |
Opioid-Related Disorders
|
| Anatomical therapeutic chemical (ATC) code |
N02AC
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Sipaco Internacional Lda.
|
| Revision |
0
|
| Date of issue of marketing authorisation valid throughout the European Union |
01/07/1997
|
| Contact address |
Sipaco Internacional, Lda.
Avenida 5 de Outubro, 267 - 6a dto 1600 Lisboa Portugal |
Product information
11/06/2002 Orlaam - EMEA/H/C/000077 -
This medicine’s product information is available in all official EU languages.
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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).
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
Analgesics
Therapeutic indication
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.