EU/3/16/1609

About

On 17 February 2016, orphan designation (EU/3/16/1609) was granted by the European Commission to Assign Group Development UK Ltd, United Kingdom, for humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s for the treatment of autoimmune haemolytic anaemia.

The sponsor changed name in November 2018. 

The sponsorship was transferred to Celerion Austria GmbH, Austria, in January 2019.

Key facts

Active substance
Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s
Disease / condition
Treatment of autoimmune haemolytic anaemia
Date of decision
17/02/2016
Outcome
Positive
Orphan decision number
EU/3/16/1609

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

Hainburger Straße 33
1030 Wien
Austria
Tel. +431403380520
E-mail: BIVV@celerion.com

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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