Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Olanzapine Cipla
Auth. number : EU/1/07/426
Active substance : 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: Adults
Olanzapine is indicated for the treatment of schizophrenia.
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Olanzapine is indicated for the treatment of moderate to severe manic episode.
In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Marketing Authorisation Holder: Cipla (EU) Limited
Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, 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
16/11/2007 Centralised - Authorisation EMEA/H/C/793 (2007)5574 of 14/11/2007
12/06/2008 Centralised - Variation EMEA/H/C/793/II/1 (2008)2734 of 10/06/2008
04/09/2008 Centralised - Variation EMEA/H/C/793/II/2 (2008)4957 of 02/09/2008
25/11/2008 Centralised - Variation EMEA/H/C/793/II/3 (2008)7466 of 21/11/2008
21/07/2009 Centralised - Variation EMEA/H/C/793/II/4 (2009)5833 of 16/07/2009
15/10/2009 Centralised - Variation EMEA/H/C/793/II/5 (2009)7963 of 13/10/2009
22/03/2010 Centralised - Variation EMEA/H/C/793/IB/6
Updated with Decision(2010)7618 of 28/10/2010
01/11/2010 Centralised - Variation (2010)7618 of 28/10/2010
03/11/2010 Centralised - Variation EMEA/H/C/793/IB/7
Updated with Decision(2011)3875 of 27/05/2011
31/05/2011 Centralised - Variation (2011)3875 of 27/05/2011
11/01/2012 Centralised - Variation EMEA/H/C/793/IB/8
Updated with Decision(2012)7050 of 01/10/2012
08/02/2012 Centralised - Variation EMEA/H/C/793/IB/8
Updated with Decision(2012)7050 of 01/10/2012
10/05/2012 Centralised - Variation EMEA/H/C/793/IA/12/G
Updated with Decision(2012)7050 of 01/10/2012
03/10/2012 Centralised - Renewal EMEA/H/C/793/R/11 (2012)7050 of 01/10/2012
16/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/793/T/13 (2013)2896 of 14/05/2013
10/07/2014 Centralised - Withdrawal (2014)4948 of 08/07/2014