EU/3/14/1363

About

On 19 November 2014, orphan designation (EU/3/14/1363) was granted by the European Commission to Coté Orphan Consulting UK Limited, United Kingdom, for 4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid for the treatment of cystic fibrosis.

The sponsorship was transferred to Quintiles Ireland Limited, Ireland, in March 2018.

In May 2018 the sponsor, Quintiles Ireland Limited changed name to IQVIA RDS Ireland Limited.

The sponsorship was transferred to FarmaStrateegia OÜ, Estonia in January 2019.

Key facts

Active substance
4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid
Disease / condition
Treatment of cystic fibrosis
Date of first decision
19/11/2014
Outcome
Positive
EU designation number
EU/3/14/1363

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

FarmaStrateegia OÜ
Veski 10-5
51005 Tartu
Estonia
Tel. +372 5070 151
E-mail: tsullivan@salamandra.net

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.
  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;

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