Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Pedea   
Auth. number : EU/1/04/284
Active substance : Ibuprofen
Orphan market exclusivity for "Treatment of patent ductus arteriosus" (based on designation EU/3/01/020) started on 02/08/2004
   10 years of market exclusivity
   This orphan market exclusivity has ended on 02/08/2014
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C01 - Cardiac therapy
Pharmacological subgroup: C01E - Other cardiac preparations
Chemical subgroup: C01EB - Other cardiac preparations
Chemical substance: C01EB16 - Ibuprofen
(See WHO ATC Index)
Indication: Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age
Marketing Authorisation Holder: Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France
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
02/08/2004 Centralised - Authorisation EMEA/H/C/549 (2004)2993 of 29/07/2004
31/08/2005 Centralised - Variation EMEA/H/C/549/II/1 (2005)3353 of 26/08/2005
07/10/2005 Corrigendum EMEA/H/C/549/II/1 (2005)3353 of 26/08/2005
03/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/549/IA/3
31/03/2006 Centralised - Variation EMEA/H/C/549/II/2 (2006)1351 of 29/03/2006
28/11/2006 Centralised - Variation EMEA/H/C/549/II/4 (2006)5852 of 24/11/2006
19/09/2007 Centralised - Variation EMEA/H/C/549/IA/5
Updated with Decision(2008)3617 of 09/07/2008
11/07/2008 Centralised - Variation (2008)3617 of 09/07/2008
30/07/2009 Centralised - Renewal EMEA/H/C/549/R/6 (2009)6077 of 24/07/2009
09/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/549/II/7
09/02/2012 Centralised - Notification EMEA/H/C/549/N/8
Updated with Decision(2014)1686 of 10/03/2014
06/07/2012 Centralised - Notification EMEA/H/C/549/N/10
Updated with Decision(2014)1686 of 10/03/2014
21/03/2013 Centralised - Variation EMEA/H/C/549/II/11
Updated with Decision(2014)1686 of 10/03/2014
19/12/2013 Centralised - Variation EMEA/H/C/549/IG/392
Updated with Decision(2014)1686 of 10/03/2014
12/03/2014 Centralised - Yearly update (2014)1686 of 10/03/2014
02/08/2014 Centralised - (orphan status)
14/02/2017 Centralised - Variation EMEA/H/C/IG/773/G