EU/3/02/107

About

On 30 July 2002, orphan designation (EU/3/02/107) was granted by the European Commission to Professor Keith Judkins, United Kingdom, for purified bromelain for the treatment of partial deep dermal and full-thickness burns.

The sponsorship was transferred to Teva Pharma GmbH, Germany, in June 2010 and subsequently to MediWound Germany GmbH, Germany, in July 2013.

Purified bromelain has been authorised in the EU as NexoBrid since 18 December 2012.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
Purified bromelain
Medicine name
NexoBrid
Disease / condition
Treatment of partial deep dermal and full-thickness burns
Date of first decision
30/07/2002
Outcome
Positive
EU designation number
EU/3/02/107

Review of designation

During its meeting of 3-4 October 2012, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/02/107 for NexoBrid (concentrate of proteolytic enzymes enriched in bromelain, previously known as purified bromelain) as an orphan medicinal product for the treatment of partial deep dermal and full-thickness burns. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other satisfactory methods of treatment. As other satisfactory methods of treatment for patients with this condition are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. The COMP recommended that the orphan designation of the medicine be maintained*.


*The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.

Sponsor's contact details

MediWound Germany GmbH
Eisenstr. 5
65428 Ruesselsheim
Germany
E-mail: info@mediwound.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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