EMA — authorised 7 January 1997
- Status: approved
🇪🇺 Orlaam in European Union
EMA authorised Orlaam on 7 January 1997
Marketing authorisations
EMA — authorised 1 July 1997
- Application: EMEA/H/C/000077
- Marketing authorisation holder: Sipaco Internacional Lda.
- Local brand name: Orlaam
- 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.
- Status: withdrawn
Orlaam in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in European Union
Frequently asked questions
Is Orlaam approved in European Union?
Yes. EMA authorised it on 7 January 1997; EMA authorised it on 1 July 1997.
Who is the marketing authorisation holder for Orlaam in European Union?
Roxane is the originator. The local marketing authorisation holder may differ — check the official source linked above.