EU/3/15/1596: Orphan designation for the treatment of partial deep dermal and full-thickness burns

Bilayer engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts

Overview

On 14 December 2015, orphan designation (EU/3/15/1596) was granted by the European Commission to Voisin Consulting S.A.R.L., France, for bilayer engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts for the treatment of partial deep dermal and full thickness burns.

Key facts

Active substance
Bilayer engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts
Intended use
Treatment of partial deep dermal and full-thickness burns
Orphan designation status
Positive
EU designation number
EU/3/15/1596
Date of designation
14/12/2015
Sponsor

Yes Pharmaceutical Development Services GmbH
Bahnstrase 42-46
61381 Friedrichsdorf
Hasse
Germany
E-mail: info@cutiss.swiss

Review of designation

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

Update history

Date Update
August 2022 The sponsorship was transferred from Voisin Consulting Life Sciences, France to Yes Pharmaceutical Development Services GmbH, Germany in August 2022.
October 2021 Voisin Consulting S.A.R.L. changed name to Voisin Consulting Life Sciences.

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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