Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Olansek
Auth. number : EU/1/96/021
INN : Olanzapine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N05 - Psycholeptics
Pharmacological subgroup: N05A - Antipsychotics
Chemical subgroup: N05AH - Diazepines, oxazepines, thiazepines and oxepines
Chemical substance: N05AH03 - Olanzapine
(See WHO ATC Index)
Indication: Antipsychotic
Marketing Authorisation Holder: Eli Lilly UK Ltd
Kingsclere Road, Basingstoke, Hampshire, United Kingdom

  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
08/10/1996 Centralised - Authorisation EMEA/H/C/114 (96)2641 of 07/10/1996
04/03/1998 Centralised - Variation EMEA/H/C/114/N/5 (1998)526 of 03/03/1998
27/03/1998 Centralised - Variation EMEA/H/C/114/II/1 (1998)749 of 26/03/1998
26/10/1998 Centralised - Variation EMEA/H/C/114/II/7 (1998)3185 of 22/10/1998
24/12/1998 Centralised - Variation EMEA/H/C/114/I/8 (1998)4498 of 17/12/1998
12/04/2000 Centralised - Variation EMEA/H/C/114/I/16
13/04/2000 Centralised - Variation EMEA/H/C/114/N/15 (2000)968 of 12/04/2000
16/05/2000 Centralised - Variation EMEA/H/C/114/I/17
26/09/2000 Centralised - Variation EMEA/H/C/114/II/14 (2000)2596 of 25/09/2000
02/01/2001 Centralised - Variation EMEA/H/C/114/II/18 (2000)4294 of 28/12/2000
15/02/2001 Centralised - Variation EMEA/H/C/114/I/20
28/02/2001 Centralised - Variation EMEA/H/C/114/I/21
13/06/2001 Centralised - Variation EMEA/H/C/114/II/19 (2001)1286 of 08/06/2001
21/11/2001 Centralised - Renewal EMEA/H/C/114/R/23 (2001)3578 of 20/11/2001
06/06/2002 Centralised - Variation EMEA/H/C/114/II/22 (2002)2087 of 04/06/2002
12/09/2002 Centralised - Variation EMEA/H/C/114/II/24 (2002)3386 of 10/09/2002
21/11/2002 Centralised - Variation EMEA/H/C/114/N/25 (2002)4588 of 20/11/2002
19/03/2003 Centralised - Withdrawal (2003)845 of 17/03/2003