EU/3/17/1835

About

On 27 February 2017, orphan designation (EU/3/17/1835) was granted by the European Commission to Ser-mes Planificación SL, Spain, for ex-vivo-expanded autologous keratinocytes transduced with retroviral vector containing the COL7A1 gene (also known as EB-101) for the treatment of epidermolysis bullosa.

Key facts

Active substance
Ex-vivo-expanded autologous keratinocytes transduced with retroviral vector containing the COL7A1 gene
Disease / condition
Treatment of epidermolysis bullosa
Date of first decision
27/02/2017
Outcome
Positive
EU designation number
EU/3/17/1835

Review of designation

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

Sponsor's contact details

Ser-mes Planificación SL
Rufino González 14, Esc.1ª-2ºD
28037 Madrid
Spain
Tel. + 34 91 375 69 30
E-mail: sermes@sermescro.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

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

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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