On 17 February 2003, orphan designation (EU/3/03/132) was granted by the European Commission to Combino Pharm, S.L., Spain, for caffeine citrate for the treatment of primary apnoea of premature newborns. The sponsorship was transferred to Chiesi Farmaceutici S.P.A., Italy, in January 2007.
Caffeine citrate has been authorised in the EU as Peyona (previously Nymusa) since 2 July 2009.
|Disease / condition||
Treatment of primary apnoea of premature newborns
|Date of decision||
|Orphan decision number||
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.