Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Zerene
Auth. number : EU/1/99/099
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: Zerene 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
Pipers väg 2A, SE-170 73 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
06/05/1999 Centralised - Variation EMEA/H/C/228/I/1
10/05/1999 Centralised - Variation EMEA/H/C/228/I/2
02/08/2000 Centralised - Variation EMEA/H/C/228/I/3, EMEA/H/C/228/N/4 (2000)2337 of 27/07/2000
22/03/2001 Centralised - Variation EMEA/H/C/228/II/5 (2001)577 of 20/03/2001
05/04/2001 Centralised - Variation EMEA/H/C/228/II/6
22/06/2001 Centralised - Variation EMEA/H/C/228/N/7 (2001)1334 of 20/06/2001
23/11/2001 Centralised - Variation EMEA/H/C/228/I/8 (2001)3594 of 21/11/2001
30/01/2002 Centralised - Variation EMEA/H/C/228/N/9 (2002)393 of 28/01/2002
12/09/2002 Centralised - Variation EMEA/H/C/228/II/10 (2002)3390 of 10/09/2002
19/03/2003 Centralised - Variation EMEA/H/C/228/N/11 (2003)854 of 17/03/2003
18/09/2003 Centralised - Variation EMEA/H/C/228/II/12 (2003)3332 of 16/09/2003
18/03/2004 Centralised - Authorisation EMEA/H/C/228 (1999)688 of 12/03/1999
02/04/2004 Centralised - Renewal EMEA/H/C/228/R/14 (2004)1326 of 31/03/2004
15/06/2004 Centralised - Variation EMEA/H/C/228/N/15
Updated with Decision(2005)2572 of 04/07/2005
06/07/2005 Centralised - Variation EMEA/H/C/228/II/16 (2005)2572 of 04/07/2005
14/06/2006 Centralised - Variation EMEA/H/C/228/II/17 (2006)2369 of 12/06/2006
11/09/2007 Centralised - Variation EMEA/H/C/228/IA/19
11/09/2007 Centralised - Variation EMEA/H/C/228/IA/20
23/11/2007 Centralised - Variation EMEA/H/C/228/II/18 (2007)5783 of 21/11/2007
22/01/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/228/T/21 (2008)303 of 18/01/2008
23/02/2009 Centralised - Renewal EMEA/H/C/228/R/22 (2009)1241 of 19/02/2009
23/06/2009 Centralised - Variation EMEA/H/C/228/IA/23
Updated with Decision(2010)597 of 27/01/2010
29/01/2010 Centralised - Variation (2010)597 of 27/01/2010
27/08/2012 Centralised - Withdrawal (2012)5998 of 23/08/2012