Pedea

RSS

ibuprofen

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 31/03/2017

Authorisation details

Product details
Name
Pedea
Agency product number
EMEA/H/C/000549
Active substance
Ibuprofen
International non-proprietary name (INN) or common name
ibuprofen
Therapeutic area (MeSH)
Ductus Arteriosus, Patent
Anatomical therapeutic chemical (ATC) code
C01EB16
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Orphan Europe S.A.R.L.
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
28/07/2004
Contact address
Orphan Europe SARL
Immeuble “Le Wilson”
70, avenue du Général de Gaulle
F-92800 Puteaux
France

Product information

13/02/2017 Pedea - EMEA/H/C/000549 - IG/773/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

CARDIAC THERAPY

Therapeutic indication

Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.

Assessment history

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