Orlaam (levacetylmethadol)
- Region
- 🇪🇺 EU
- Active substance
- levacetylmethadol
- Company
- Sipaco Internacional Lda.
- Status
- Withdrawn
- Therapeutic area
- Opioid-Related Disorders
- EU approval
- Tue 01 Jul 1997
- Application
- EMEA/H/C/000077
- ATC
- N02AC
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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