Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Orlaam
Auth. number : EU/1/97/041
Active substance : Levacetylmethadol
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N07 - Other nervous system drugs
Pharmacological subgroup: N07B - Drugs used in addictive disorders
Chemical subgroup: N07BC - Drugs used in opioid dependence
Chemical substance: N07BC03 - efavirenz
(See WHO ATC Index)
Indication: Substitution maintainance treatment of opiate addiction
Marketing Authorisation Holder: Sipaco Internacional Lda
Avenida 5 de Outubro, 267-6° dto, 1600 Lisboa, Portugal
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
02/07/1997 Centralised - Authorisation EMEA/H/C/77 (97)2010 of 01/07/1997
18/03/1998 Centralised - Authorisation EMEA/H/C/77/II/1 (1998)669 of 16/03/1998
28/01/1999 Centralised - Variation EMEA/H/C/77/I/2 (1999)99 of 26/01/1999
06/05/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/77/I/4
14/07/2000 Centralised - Variation EMEA/H/C/77/II/5 (2000)1749 of 05/07/2000
23/07/2001 Centralised - Suspension of martketing authorisation EMEA/H/C/77/Z/6 (2001)2028 of 19/07/2001
18/05/2002 Centralised - Withdrawal (2002)2210 of 11/05/2002