EU/3/11/896: Orphan designation for the treatment of cystic fibrosis

Multilamellar microvesicle comprising phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol and cholesterol

Overview

On 30 August 2011, orphan designation (EU/3/11/896) was granted by the European Commission to Lamellar Biomedical Ltd, United Kingdom, for multilamellar microvesicle comprising phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol and cholesterol for treatment of cystic fibrosis.

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

In August 2020, Clinical Network Services (NL) B.V.changed name to Scendea (NL) B.V.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in April 2022 on request of the Sponsor.

Key facts

Active substance
Multilamellar microvesicle comprising phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol and cholesterol
Intended use
Treatment of cystic fibrosis
Orphan designation status
Withdrawn
EU designation number
EU/3/11/896
Date of designation
30/08/2011
Sponsor

Scendea (NL) B.V.
De Cuserstraat 93
1081 CN Amsterdam
Noord-Holland
Netherlands
Tel. +31 2089 49169
E-mail: orphan@scendea.com

Review of designation

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

Documents related to this orphan designation evaluation

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.

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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