Orlaam
Withdrawn
This medicine's authorisation has been withdrawn
levacetylmethadol
Medicine
Human
Withdrawn
- 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The marketing authorisation for Orlaam has been withdrawn at the request of the marketing authorisation holder.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.
Select 'available languages' to access the language you need.
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
AnalgesicsTherapeutic 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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