Human medicines European public assessment report (EPAR): Ibuprofen Gen.Orph, ibuprofen, Date of authorisation: 16/02/2024, Revision: 4, Status: Authorised

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

Ibuprofen Gen.Orph is a medicine used to treat ‘patent ductus arteriosus’ in newborn premature babies who were born six or more weeks too early (less than 34 weeks gestational age). Patent ductus arteriosus is a condition where the ductus arteriosus (the blood vessel that allows blood to bypass the baby’s lungs before birth) fails to close after birth. This causes heart and lung problems in the baby.

Ibuprofen Gen.Orph is a ‘generic medicine’. This means that Ibuprofen Gen.Orph contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU.

Ibuprofen Gen.Orph contains the active substance ibuprofen.

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How is Ibuprofen Gen.Orph used?

Treatment with Ibuprofen Gen.Orph should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist (a doctor specialising in newborn babies).

Ibuprofen Gen.Orph is given as three injections into a vein at 24-hour intervals. Each injection lasts 15 minutes. The first injection is given when the baby is at least six hours old. If the ductus arteriosus has not closed by 48 hours after the final injection, or if it re-opens, a second course of three doses of Ibuprofen Gen.Orph may be given. If the condition is unchanged after the second course of therapy, surgery may be necessary.

Ibuprofen Gen.Orph should not be used before there is proof that the baby has patent ductus arteriosus.

For more information about using Ibuprofen Gen.Orph, see the package leaflet or contact your doctor or pharmacist.

How does Ibuprofen Gen.Orph work?

The active substance in Ibuprofen Gen.Orph, ibuprofen, has been used since the 1960s as a painkiller and an anti-inflammatory medicine. It works by reducing the level of chemical messengers called prostaglandins within cells. As prostaglandins are also involved in keeping the ductus arteriosus open after birth, Ibuprofen Gen.Orph is thought to work by reducing the levels of prostaglandins, allowing this blood vessel to close.

How has Ibuprofen Gen.Orph been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Pedea, and do not need to be repeated for Ibuprofen Gen.Orph.

As for every medicine, the company provided studies on the quality of Ibuprofen Gen.Orph. There was no need for ‘bioequivalence’ studies to investigate whether Ibuprofen Gen.Orph is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Ibuprofen Gen.Orph is given by injection into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Ibuprofen Gen.Orph?

Because Ibuprofen Gen.Orph is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Ibuprofen Gen.Orph authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Ibuprofen Gen.Orph has been shown to be comparable to Pedea. Therefore, the Agency’s view was that, as for Pedea, the benefits of Ibuprofen Gen.Orph outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Ibuprofen Gen.Orph?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ibuprofen Gen.Orph have been included in the summary of product characteristics and the package leaflet.

Any additional measures in place for Pedea, such as a patient card with key safety information, also apply to Ibuprofen Gen.Orph where appropriate.

As for all medicines, data on the use of Ibuprofen Gen.Orph are continuously monitored. Suspected side effects reported with Ibuprofen Gen.Orph are carefully evaluated and any necessary action taken to protect patients.

Other information about Ibuprofen Gen.Orph

Ibuprofen Gen.Orph received a marketing authorisation valid throughout the EU on 16 February 2024.

Ibuprofen Gen.Orph : EPAR - Medicine overview

Reference Number:

EMA/73760/2024

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Ibuprofen Gen.Orph : EPAR - Risk management plan

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Product information

Ibuprofen Gen.Orph : EPAR - Product information

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Latest procedure affecting product information:

VR/0000350277

25/06/2026

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).

Ibuprofen Gen.Orph : EPAR - All authorised presentations

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Product details

Name of medicine

Ibuprofen Gen.Orph

Active substance

Ibuprofen

International non-proprietary name (INN) or common name

ibuprofen

Therapeutic area (MeSH)

Ductus Arteriosus, Patent

Anatomical therapeutic chemical (ATC) code

C01EB16

Pharmacotherapeutic group

Other cardiac preparations

Therapeutic indication

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

Authorisation details

EMA product number

EMEA/H/C/006129

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder

Gen.Orph

185 Bureaux de la Colline 92213 Saint Cloud Cedex France

Marketing authorisation issued

16/02/2024

Revision

4

Assessment history

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Changes since initial authorisation of medicine

Ibuprofen Gen.Orph : EPAR - Procedural steps taken and scientific information after authorisation

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First published:

28/05/2025

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29/06/2026

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Ibuprofen Gen.Orph : EPAR - Procedural steps taken and scientific information after authorisation (archive)

English (EN) (99.61 KB - PDF)

First published:

31/10/2024

Last updated:

28/05/2025

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Initial marketing authorisation documents

Ibuprofen Gen.Orph : EPAR - Public assessment report

Reference Number:

EMA/586586/2023

English (EN) (331 KB - PDF)

First published:

12/03/2024

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CHMP initial authorisation summary of positive opinion for Ibuprofen Gen.Orph

Adopted

Reference Number:

EMA/CHMP/562650/2023

English (EN) (131.43 KB - PDF)

First published:

15/12/2023

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News on Ibuprofen Gen.Orph

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2023

15/12/2023

This page was last updated on

29/06/2026