EU/3/18/2094

About

On 19 November 2018, orphan designation (EU/3/18/2094) was granted by the European Commission to Y-mAbs Therapeutics A/S, Denmark, for anti-GD2 monoclonal antibody 3F8 humanised (also known as naxitamab) for the treatment of neuroblastoma.

Key facts

Active substance
Anti-GD2 monoclonal antibody 3F8 humanised
Disease / condition
Treatment of neuroblastoma
Date of decision
19/11/2018
Outcome
Positive
Orphan decision number
EU/3/18/2094

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

Y-mAbs Therapeutics A/S
Agern Allé 11
2970 Hoersholm
Denmark
Telephone: +45 7026 1414
E-mail: info@ymabs.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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