Orlaam

RSS

levacetylmethadol

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Orlaam has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 30/06/2002

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 -

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.

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