Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Circadin   
Auth. number : EU/1/07/392
INN : Melatonin
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N05 - Psycholeptics
Pharmacological subgroup: N05C - Hypnotics and sedatives
Chemical subgroup: N05CH - Melatonin receptor agonists
Chemical substance: N05CH01 - Melatonin
(See WHO ATC Index)
Indication: indicated as monotherapy for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over
Marketing Authorisation Holder: RAD Neurim Pharmaceuticals EEC Limited
One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, 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
05/07/2007 Centralised - Authorisation EMEA/H/C/695 (2007)3286 of 29/06/2007
27/09/2007 Centralised - Variation EMEA/H/C/695/IB/2
08/10/2007 Centralised - Variation EMEA/H/C/695/N/1
Updated with Decision(2008)3616 of 09/07/2008
06/12/2007 Centralised - Variation EMEA/H/C/695/IA/5
Updated with Decision(2008)3616 of 09/07/2008
11/01/2008 Centralised - Variation EMEA/H/C/695/N/3
Updated with Decision(2008)3616 of 09/07/2008
16/01/2008 Centralised - Variation EMEA/H/C/695/IA/6
Updated with Decision(2008)3616 of 09/07/2008
21/02/2008 Centralised - Variation EMEA/H/C/695/IA/10
Updated with Decision(2008)3616 of 09/07/2008
28/02/2008 Centralised - Variation EMEA/H/C/695/IB/8
04/03/2008 Centralised - Variation EMEA/H/C/695/IB/7
11/07/2008 Centralised - Variation (2008)3616 of 09/07/2008
31/07/2008 Centralised - Variation EMEA/H/C/695/II/11 (2008)4173 of 29/07/2008
23/10/2008 Centralised - Variation EMEA/H/C/695/IB/13
27/02/2009 Centralised - Variation EMEA/H/C/695/II/16
27/02/2009 Centralised - Variation EMEA/H/C/695/II/15
19/03/2009 Centralised - Variation EMEA/H/C/695/IA/17
Updated with Decision(2009)7850 of 08/10/2009
26/03/2009 Centralised - Variation EMEA/H/C/695/II/14
17/07/2009 Centralised - Variation EMEA/H/C/695/IB/18
12/10/2009 Centralised - Variation (2009)7850 of 08/10/2009
18/12/2009 Centralised - Variation EMEA/H/C/695/II/20 (2009)9347 of 20/11/2009
22/04/2010 Centralised - Variation EMEA/H/C/695/IA/21/G
Updated with Decision(2010)3642 of 02/06/2010
07/06/2010 Centralised - Variation EMEA/H/C/695/II/19 (2010)3642 of 02/06/2010
07/07/2010 Centralised - Variation EMEA/H/C/695/N/22
Updated with Decision(2010)8541 of 26/11/2010
03/09/2010 Centralised - Variation EMEA/H/C/695/IA/24/G
Updated with Decision(2010)8541 of 26/11/2010
02/12/2010 Centralised - Variation EMEA/H/C/695/II/23 (2010)8541 of 26/11/2010
12/01/2011 Centralised - Variation EMEA/H/C/695/IB/25
Updated with Decision(2011)6419 of 07/09/2011
05/08/2011 Centralised - Variation EMEA/H/C/695/IA/26
Updated with Decision(2012)1040 of 13/02/2012
12/08/2011 Centralised - Variation EMEA/H/C/695/N/27
Updated with Decision(2012)1040 of 13/02/2012
05/09/2011 Centralised - Variation EMEA/H/C/695/N/28
Updated with Decision(2012)1040 of 13/02/2012
13/09/2011 Centralised - Variation (2011)6419 of 07/09/2011
13/10/2011 Centralised - Variation EMEA/H/C/695/N/30
Updated with Decision(2012)1040 of 13/02/2012
15/02/2012 Centralised - Variation (2012)1040 of 13/02/2012
25/04/2012 Centralised - Renewal EMEA/H/C/695/R/31 (2012)2841 of 20/04/2012
22/06/2012 Centralised - Variation EMEA/H/C/695/N/32
Updated with Decision(2013)5447 of 12/08/2013
08/08/2012 Centralised - Variation EMEA/H/C/695/N/33
Updated with Decision(2013)5447 of 12/08/2013
28/09/2012 Centralised - Variation EMEA/H/C/695/N/34
Updated with Decision(2013)5447 of 12/08/2013
18/01/2013 Centralised - Variation EMEA/H/C/695/IAin/35/G
Updated with Decision(2013)5447 of 12/08/2013
27/03/2013 Centralised - Variation EMEA/H/C/695/N/695
Updated with Decision(2013)5447 of 12/08/2013
21/05/2013 Centralised - Variation EMEA/H/C/695/IAin/37/G
Updated with Decision(2013)5447 of 12/08/2013
04/07/2013 Centralised - Variation EMEA/H/C/695/IB/38
Updated with Decision(2014)4508 of 27/06/2014
14/08/2013 Centralised - Modification EMEA/H/C/695/PSU/15 (2013)5447 of 12/08/2013
13/09/2013 Centralised - Variation EMEA/H/C/695/IAin/41
Updated with Decision(2014)4508 of 27/06/2014
26/02/2014 Centralised - Variation EMEA/H/C/695/N/45
Updated with Decision(2014)4508 of 27/06/2014
01/07/2014 Centralised - Variation (2014)4508 of 27/06/2014