EU/3/13/1218

About

On 16 January 2014, orphan designation (EU/3/13/1218) was granted by the European Commission to Proteon Therapeutics Limited, United Kingdom, for recombinant human type I pancreatic elastase for the prevention of arteriovenous access dysfunction in haemodialysis patients.

This medicine is now known as vonapanitase.

The sponsorship was transferred to Pharma Gateway AB Sweden, in April 2019.

Key facts

Active substance
Recombinant human type I pancreatic elastase for the prevention of arteriovenous access dysfunction in haemodialysis patients (vonapanitase)
Disease / condition
Prevention of arteriovenous access dysfunction in haemodialysis patients
Date of first decision
16/01/2014
Outcome
Positive
EU designation number
EU/3/13/1218

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

Pharma Gateway AB
Johanneslundsvägen 2
194 81 Upplands Väsby
Sweden
Tel. +46 8 590 778 00
E-mail: info@pharmagateway.eu

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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