EU/3/14/1289: Orphan designation for the treatment of pre-eclampsia

Recombinant human alpha-1-microglobulin


Please note that this product was withdrawn from the Union Register of orphan medicinal products in May 2021 on request of the Sponsor.

On 4 July 2014, orphan designation (EU/3/14/1289) was granted by the European Commission to A1M Pharma AB, Sweden, for recombinant human alpha-1-microglobulin for the treatment of pre‑eclampsia.

In April 2021, A1M Pharma AB changed name to Guard Therapeutics International AB.

Key facts

Active substance
Recombinant human alpha-1-microglobulin
Intended use
Treatment of pre-eclampsia
Orphan designation status
EU designation number
Date of designation

Scheelevägen 22
223 63 Lund
Tel. +46 46 286 50 30

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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