Orphan designation: (4R)-3-(4-fluoro-2-hydroxyphenyl)-4-methyl-4,5-dihydro-1H-pyrazole-1-carboximidamide hydrochloride Treatment of systemic sclerosis, 12/01/2024 Positive

Overview

Metadata
Provider: 
European Medicines AgencyEuropean Medicines Agency
URL: 
https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2874https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2874
Retrieved on: 
Thursday, April 18, 2024
Information
Tags: 
Patient, Committee, EMA, IRIS, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry
Geotags: 
RARE, EU
Summary
Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of systemic sclerosis on 12 January 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • 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:
Copyright: 
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