On 16 November 2004, orphan designation (EU/3/04/241) was granted by the European Commission to Uppsala Medical Information System AB, Sweden, for pirfenidone for the treatment of idiopathic pulmonary fibrosis.

Pirfenidone has been authorised in the EU as Esbriet since 28 February 2011.

The sponsorship was transferred to Intermune Europe Limited, United Kingdom, in May 2009. Intermune Europe Limited has changed its name to InterMune UK Limited in March 2011.

The sponsorship was transferred to Roche Registration Limited, United Kingdom, in February 2015 and subsequently to Roche Registration GmbH, Germany, in March 2018.

Key facts

Active substance
Medicine name
Disease / condition
Treatment of idiopathic pulmonary fibrosis
Date of decision
Orphan decision number

Review of designation

During its meeting of 8-9 February 2011, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/04/241 for Esbriet (pirfenidone) as an orphan medicinal product for the treatment of idiopathic pulmonary fibrosis. 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. 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 European Union. 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

Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Tel. +49 7624 142892

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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