EU/3/15/1498

About

On 21 May 2015, orphan designation (EU/3/15/1498) was granted by the European Commission to Clinical Network Services (UK) Ltd, United Kingdom, for 2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl)acetamide for the treatment of cystic fibrosis.

The sponsorship was transferred to Clinical Network Services (NL) B.V., The Netherlands, in January 2019.

Key facts

Active substance
2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl) acetamide
Disease / condition
Treatment of cystic fibrosis
Date of decision
21/05/2015
Outcome
Positive
Orphan decision number
EU/3/15/1498

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

Clinical Network Services (NL) B.V.
De Cuserstraat 93
1081 CN Amsterdam
The Netherlands
Tel. +31 2089 49169
E-mail: cns@clinical.net.au

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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