Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Peyona   
Auth. number : EU/1/09/528
Active substance : Caffeine citrate
Orphan market exclusivity for "Treatment of primary apnoea of premature newborns" (based on designation EU/3/03/132) started on 06/07/2009
   10 years of market exclusivity
   This orphan market exclusivity will expire on 06/07/2019
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N06 - Psychoanaleptics
Pharmacological subgroup: N06B - Psychostimulants
Chemical subgroup: N06BC - Xanthine derivatives
Chemical substance: N06BC01 - Caffeine
(See WHO ATC Index)
Indication: Treatment of primary apnoea of premature newborns.
Marketing Authorisation Holder: Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia
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
03/07/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1014 (2009)5464 of 02/07/2009
06/07/2009 Centralised - Authorisation EMEA/H/C/1014 (2009)5463 of 02/07/2009
08/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1014/IA/1
08/06/2010 Centralised - Variation EMEA/H/C/1014/II/2 (2010)3710 of 04/06/2010
25/11/2010 Centralised - Variation EMEA/H/C/1014/IA/4
Updated with Decision(2011)923 of 09/02/2011
21/12/2010 Centralised - Variation EMEA/H/C/1014/IA/3
Updated with Decision(2011)923 of 09/02/2011
11/02/2011 Centralised - Variation (2011)923 of 09/02/2011
27/10/2011 Centralised - Variation EMEA/H/C/1014/IA/5
Updated with Decision(2012)3714 of 31/05/2012
11/01/2012 Centralised - Notification EMEA/H/C/1014/N/6
Updated with Decision(2012)3714 of 31/05/2012
04/06/2012 Centralised - Variation (2012)3714 of 31/05/2012
13/08/2013 Centralised - Notification EMEA/H/C/1014/N/10
Updated with Decision(2014)1505 of 03/03/2014
05/03/2014 Centralised - Renewal EMEA/H/C/1014/R/11 (2014)1505 of 03/03/2014
26/02/2015 Centralised - Variation EMEA/H/C/1014/II/13
Updated with Decision(2016)1286 of 24/02/2016
26/02/2016 Centralised - Yearly update (2016)1286 of 24/02/2016
19/04/2017 Centralised - Variation EMEA/H/C/1014/IB/17
21/09/2017 Centralised - Variation EMEA/H/C/1014/IAIIN/19