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 08/11/2022

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
Publication details
Marketing-authorisation holder
Recordati Rare Diseases
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
28/07/2004
Contact address

Immeuble le Wilson
70, avenue du Général de Gaulle
92800 Puteaux
France

Product information

07/11/2022 Pedea - EMEA/H/C/000549 - IA/0032

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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