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Pharmaceuticals - Union Register
Union 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 6/07/2009 10 years of market exclusivity This orphan market exclusivity will expire on 6/07/2019 | |
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 Union Register. |
European Commission procedures |
Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
3/07/2009 | Centralised - Authorisation - Decision addressed to Member States | EMEA/H/C/1014 | (2009)5464 of 2/07/2009 | |||
6/07/2009 | Centralised - Authorisation | EMEA/H/C/1014 | (2009)5463 of 2/07/2009 | |||
8/03/2010 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/1014/IA/1 | ||||
8/06/2010 | Centralised - Variation | EMEA/H/C/1014/II/2 | (2010)3710 of 4/06/2010 | |||
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 9/02/2011 | ||||
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 | ||||||
4/06/2012 | 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 | ||||||
5/03/2014 | Centralised - Renewal | EMEA/H/C/1014/R/11 | (2014)1505 of 3/03/2014 | |||
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 | ||||
Updated with Decision(2018)2498 of 19/04/2018 | ||||||
21/09/2017 | Centralised - Variation | EMEA/H/C/1014/IAIN/19 | ||||
Updated with Decision(2018)2498 of 19/04/2018 | ||||||
23/04/2018 | Centralised - Yearly update | (2018)2498 of 19/04/2018 |