Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Olanzapine Mylan   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Оланзапин Mylan (BG)
   - Olanzapinum Mylan (CS)
   - Оlanzapin Mylan (DA)
   - Оlanzapin Mylan (DE)
   - Oλανζαπίνη Mylan (EL)
   - Оlanzapina Mylan (ES)
   - Olansapiin Mylan (ET)
   - Оlanzapine Mylan (FI)
   - Olanzapin Mylan (HU)
   - Olanzapina Mylan (IT)
   - Olanzapinas Mylan (LT)
   - Olanzapina Mylan (PL)
   - Olanzapina Mylan (PT)
   - Olanzapină Mylan (RO)
   - Olanzapín Mylan (SK)
Auth. number : EU/1/08/475
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: Olanzapine is indicated for the treatment of schizophrenia and for the treatment of moderate to severe manic episode (adults).
Marketing Authorisation Holder: Generics [UK] Limited
Station Close, Potters Bar, Hertfordshire, EN6 1TL, 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
09/10/2008 Centralised - Authorisation EMEA/H/C/961 (2008)5941 of 07/10/2008
21/07/2009 Centralised - Variation EMEA/H/C/961/II/1 (2009)5872 of 17/07/2009
27/10/2009 Centralised - Variation EMEA/H/C/961/II/2 (2009)8402 of 23/10/2009
22/12/2009 Centralised - Variation EMEA/H/C/961/IA/15
Updated with Decision(2010)5605 of 06/08/2010
22/12/2009 Centralised - Variation EMEA/H/C/961/IA/14
Updated with Decision(2010)5605 of 06/08/2010
22/12/2009 Centralised - Variation EMEA/H/C/961/IA/13
Updated with Decision(2010)5605 of 06/08/2010
22/12/2009 Centralised - Variation EMEA/H/C/961/IA/6
Updated with Decision(2010)5605 of 06/08/2010
22/12/2009 Centralised - Variation EMEA/H/C/961/IA/12
Updated with Decision(2010)5605 of 06/08/2010
22/12/2009 Centralised - Variation EMEA/H/C/961/IA/8
22/12/2009 Centralised - Variation EMEA/H/C/961/IA/7
22/12/2009 Centralised - Variation EMEA/H/C/961/IA/11
22/12/2009 Centralised - Variation EMEA/H/C/961/IA/10
22/12/2009 Centralised - Variation EMEA/H/C/961/IA/5
22/12/2009 Centralised - Variation EMEA/H/C/961/IA/9
25/01/2010 Centralised - Variation EMEA/H/C/961/IB/4
25/01/2010 Centralised - Variation EMEA/H/C/961/IB/3
23/03/2010 Centralised - Variation EMEA/H/C/961/IB/16
Updated with Decision(2010)7736 of 03/11/2010
20/07/2010 Centralised - Variation EMEA/H/C/961/IB/17
10/08/2010 Centralised - Variation (2010)5605 of 06/08/2010
09/11/2010 Centralised - Variation (2010)7736 of 03/11/2010
15/11/2010 Centralised - Variation EMEA/H/C/961/IB/18
Updated with Decision(2011)4398 of 16/06/2011
05/01/2011 Centralised - Variation EMEA/H/C/961/IA/19/G
21/06/2011 Centralised - Variation (2011)4398 of 16/06/2011
05/07/2011 Centralised - Variation EMEA/H/C/961/IB/21/G
Updated with Decision(2012)195 of 13/01/2012
06/07/2011 Centralised - Variation EMEA/H/C/961/IB/20
Updated with Decision(2012)195 of 13/01/2012
12/10/2011 Centralised - Variation EMEA/H/C/961/IA/27/G
Updated with Decision(2012)195 of 13/01/2012
12/10/2011 Centralised - Variation EMEA/H/C/961/IB/28
Updated with Decision(2012)195 of 13/01/2012
18/01/2012 Centralised - Variation (2012)195 of 13/01/2012
19/01/2012 Centralised - Variation EMEA/H/C/961/IB/29/G
Updated with Decision(2012)5690 of 03/08/2012
07/08/2012 Centralised - Variation (2012)5690 of 03/08/2012
26/09/2012 Centralised - Variation EMEA/H/C/961/IB/30
Updated with Decision(2012)7735 of 25/10/2012
29/10/2012 Centralised - Variation (2012)7735 of 25/10/2012
24/05/2013 Centralised - Renewal EMEA/H/C/961/R/32 (2013)3107 of 22/05/2013
19/08/2013 Centralised - Variation EMEA/H/C/961/IB/33
31/10/2013 Centralised - Variation EMEA/H/C/961/IB/34/G