Orphan designation: Azithromycin dihydrate Prevention of bronchopulmonary dysplasia, 14/01/2022 Positive

Overview

Metadata
Provider: 
European Medicines AgencyEuropean Medicines Agency
URL: 
https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2568https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2568
Retrieved on: 
Tuesday, April 9, 2024
Information
Tags: 
Community, Diagnosis, Civil service commission, Bronchopulmonary dysplasia, Ureaplasma urealyticum infection, BPD, Prevalence, Protein, Disease, Infection, Clinical, Inflammation, Patient, Committee, Bacteria, EMA, IRIS, Update, Agency, European, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry
Geotags: 
EUROPEAN UNION, RARE, MALTA, EU
Summary
Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the prevention of bronchopulmonary dysplasia in the European Union on 14 January 2022.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • The full list of orphan designations is available in the Community register of orphan medicinal products for human use.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
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