Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zypadhera   
Auth. number : EU/1/08/479
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: Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.
Marketing Authorisation Holder: Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland

  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
21/11/2008 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/890 (2008)7398 of 19/11/2008
24/11/2008 Centralised - Authorisation EMEA/H/C/890 (2008)7397 of 19/11/2008
15/12/2008 Centralised - Variation EMEA/H/C/890/IA/1
Updated with Decision(2009)6062 of 24/07/2009
19/06/2009 Centralised - Variation EMEA/H/C/890/IA/3
Updated with Decision(2009)10706 of 21/12/2009
30/07/2009 Centralised - Variation EMEA/H/C/890/II/2 (2009)6062 of 24/07/2009
23/12/2009 Centralised - Variation EMEA/H/C/890/II/4 (2009)10706 of 21/12/2009
06/09/2010 Centralised - Variation EMEA/H/C/890/WS/21 (2010)6148 of 01/09/2010
16/02/2011 Centralised - Variation EMEA/H/C/890/IB/7
16/02/2011 Centralised - Variation EMEA/H/C/890/IB/6
16/09/2011 Centralised - Variation (2011)6518 of 13/09/2011
16/09/2011 Centralised - Variation EMEA/H/C/890/IAin/8
Updated with Decision(2011)6518 of 13/09/2011
16/09/2011 Centralised - Variation EMEA/H/C/890/N/5
Updated with Decision(2011)6518 of 13/09/2011
24/10/2011 Centralised - Variation EMEA/H/C/890/WS/182 (2011)7670 of 20/10/2011
28/11/2011 Centralised - Variation EMEA/H/C/890/WS/127 (2011)8844 of 24/11/2011
29/06/2012 Centralised - Variation EMEA/H/C/890/II/WS/215 (2012)4491 of 27/06/2012
21/02/2013 Centralised - Variation EMEA/H/C/890/II/18
Updated with Decision(2013)3218 of 27/05/2013
29/05/2013 Centralised - Variation EMEA/H/C/890/WS/337 (2013)3218 of 27/05/2013
29/08/2013 Centralised - Renewal EMEA/H/C/890/R/19 (2013)5616 of 26/08/2013
25/04/2014 Centralised - Variation EMEA/H/C/890/II/22