Pedea (ibuprofen)
- Region
- 🇪🇺 EU
- Active substance
- ibuprofen
- Company
- Recordati Rare Diseases
- Status
- Authorised
- Therapeutic area
- Ductus Arteriosus, Patent
- EU approval
- Wed 28 Jul 2004
- Application
- EMEA/H/C/000549
- ATC
- C01EB16
- Official record
- www.ema.europa.eu
Indication
Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Vlustozik (previously Ibuprofen Gen.Orph) Authorised · Gen.Orph
- 🇪🇺 Ibuprofen Gen.Orph Authorised · Gen.Orph
- 🇪🇺 Ibuprofen/Diphenhydramine Hydrochloride Wyeth Application withdrawn · Wyeth Consumer Healthcare
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.