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).
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 |
Product information
07/11/2022 Pedea - EMEA/H/C/000549 - IA/0032
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.