Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sonata   
Auth. number : EU/1/99/102
INN : Zaleplon
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N05 - Psycholeptics
Pharmacological subgroup: N05C - Hypnotics and sedatives
Chemical subgroup: N05CF - Cyclopyrrolones
Chemical substance: N05CF03 - Zaleplon
(See WHO ATC Index)
Indication: Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.
Marketing Authorisation Holder: Meda AB
Box 906, SE-170 09 Solna, Sverige

  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
18/03/1999 Centralised - Authorisation EMEA/H/C/227 (1999)689 of 12/03/1999
14/03/2000 Centralised - Variation EMEA/H/C/227/I/3, 5 (2000)602 of 09/03/2000
07/06/2000 Centralised - Notification EMEA/H/C/227/N/6 (2000)1449 of 31/05/2000
22/03/2001 Centralised - Variation EMEA/H/C/227/II/7 (2001)578 of 20/03/2001
05/04/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/227/II/8
22/06/2001 Centralised - Notification EMEA/H/C/227/N/9 (2001)1333 of 20/06/2001
23/11/2001 Centralised - Variation EMEA/H/C/227/I/10 (2001)3597 of 21/11/2001
30/01/2002 Centralised - Notification EMEA/H/C/227/N/11 (2002)401 of 28/01/2002
12/09/2002 Centralised - Variation EMEA/H/C/227/II/12 (2002)3392 of 10/09/2002
19/03/2003 Centralised - Notification EMEA/H/C/227/N/13 (2003)847 of 17/03/2003
18/09/2003 Centralised - Variation EMEA/H/C/227/I/14 (2003)3341 of 16/09/2003
02/04/2004 Centralised - Renewal EMEA/H/C/227/R/16 (2004)1324 of 31/03/2004
15/06/2004 Centralised - Notification EMEA/H/C/227/N/17
Updated with Decision(2005)2573 of 04/07/2005
06/07/2005 Centralised - Variation EMEA/H/C/227/II/18 (2005)2573 of 04/07/2005
14/06/2006 Centralised - Variation EMEA/H/C/227/II/19 (2006)2372 of 12/06/2006
13/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/227/IA/22
13/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/227/IA/21
23/11/2007 Centralised - Variation EMEA/H/C/227/II/20 (2007)5785 of 21/11/2007
17/12/2007 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/227/T/23 (2007)6458 of 12/12/2007
01/09/2008 Centralised - Variation EMEA/H/C/227/IA/25
Updated with Decision(2009)1240 of 19/02/2009
02/09/2008 Centralised - Variation EMEA/H/C/227/IA/24
Updated with Decision(2009)1240 of 19/02/2009
23/02/2009 Centralised - Renewal EMEA/H/C/227/R/26 (2009)1240 of 19/02/2009
24/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/227/IA/28
03/07/2009 Centralised - Variation EMEA/H/C/227/IA/27
Updated with Decision(2010)596 of 27/01/2010
29/01/2010 Centralised - Variation (2010)596 of 27/01/2010
08/02/2012 Centralised - Variation EMEA/H/C/227/II/31/G (2012)765 of 06/02/2012
23/10/2014 Centralised - Variation EMEA/H/C/227/II/33