🇪🇺 Ibuprofen + Paracetamol in European Union

EMA authorised Ibuprofen + Paracetamol on 28 July 2004

Marketing authorisations

EMA — authorised 28 July 2004

• Application: EMEA/H/C/000549
• Marketing authorisation holder: Recordati Rare Diseases
• Local brand name: Pedea
• Indication: Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
• Status: approved

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EMA — authorised 31 December 2009

• Application: EMEA/H/C/001108
• Marketing authorisation holder: Wyeth Consumer Healthcare
• Local brand name: Ibuprofen/Diphenhydramine Hydrochloride Wyeth
• Status: withdrawn

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EMA — authorised 16 February 2024

• Application: EMEA/H/C/006129
• Marketing authorisation holder: Gen.Orph
• Local brand name: Ibuprofen Gen.Orph
• Indication: Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age
• Status: approved

On 16 February 2024, the European Medicines Agency (EMA) granted marketing authorisation for Ibuprofen Gen.Orph, a fixed-dose combination of ibuprofen and paracetamol. This authorisation allows the treatment of haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age. The marketing authorisation holder is Gen.Orph, and the local brand name is Ibuprofen Gen.Orph.

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Frequently asked questions

Is Ibuprofen + Paracetamol approved in European Union?

Yes. EMA authorised it on 28 July 2004; EMA authorised it on 31 December 2009; EMA authorised it on 16 February 2024.

Who is the marketing authorisation holder for Ibuprofen + Paracetamol in European Union?

Recordati Rare Diseases holds the EU marketing authorisation.