Orlaam

Application under evaluation
CHMP opinion
European Commission decision

Overview

The marketing authorisation for Orlaam has been withdrawn at the request of the marketing authorisation holder.

Product information

11/06/2002

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).

Product details

Name of medicine: Orlaam
Active substance: levacetylmethadol
International non-proprietary name (INN) or common name: levacetylmethadol
Therapeutic area (MeSH): Opioid-Related Disorders
Anatomical therapeutic chemical (ATC) code: N02AC

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.

Authorisation details

EMA product number: EMEA/H/C/000077
Marketing authorisation holder: Sipaco Internacional Lda.
Sipaco Internacional, Lda.
Avenida 5 de Outubro, 267 - 6a dto
1600 Lisboa
Portugal
Marketing authorisation issued: 01/07/1997

This page was last updated on 30/06/2002

Withdrawn