Orphan designation: (S)-N-(1-(3-Fluoro-2'-methoxy-[1,1'-biphenyl]-4-yl)-2-oxopiperidin-3-yl)-5-(pyridin-2-yl)thiophene-2-sulfonamide Treatment of soft-tissue sarcoma, 13/12/2023 Positive

Key facts

Metadata

Provider: 

European Medicines Agency

URL: 

https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2861

Retrieved on: 

Sunday, February 4, 2024

Information

Tags: 

COMP, IRIS, European Commission, Soft-tissue sarcoma, Committee, Patient, EMA, Pharmaceutical industry

Geotags: 

RARE, EU

Summary

Key Points: 

• Key facts
  - Active substance
  - (S)-N-(1-(3-Fluoro-2'-methoxy-[1,1'-biphenyl]-4-yl)-2-oxopiperidin-3-yl)-5-(pyridin-2-yl)thiophene-2-sulfonamide
  - Intended use
  - Treatment of soft-tissue sarcoma
  - Orphan designation status
  - Positive
  - EU designation number
  - EU/3/23/2861
  - Date of designation
  - Sponsor
  Selabtec Sciences S.L.
• Patients' organisations
  For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
  European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
• 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:
  EMA list of opinions on orphan medicinal product designation
  EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Copyright: 

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