EU/3/10/826

About

On 17 December 2010, orphan designation (EU/3/10/826) was granted by the European Commission to Lucane Pharma SAS, France, for para-aminosalicylic acid for the treatment of tuberculosis.

The sponsorship was transferred to Lucane Pharma SA, France, in February 2012.

Para-aminosalicylic acid has been authorised in the EU as Granupas since 7 April 2014.

The sponsorship was transferred to Eurocept International B.V., The Netherlands, in May 2018.

Key facts

Active substance
Para-aminosalicylic acid
Medicine name
Granupas
Disease / condition
Treatment of tuberculosis
Date of first decision
17/12/2010
Outcome
Positive
EU designation number
EU/3/10/826

Review of designation

During its meeting of 4 to 6 February 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/10/826 for Granupas, previously Para-aminosalicylic acid Lucane (para-aminosalicylic acid) as an orphan medicinal product for the treatment of tuberculosis. 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 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.

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

Sponsor's contact details

Eurocept International B.V.
Trapgans 5
1244 RL Ankeveen
The Netherlands
Tel. +31 3552 83957
E-mail: regulatory@eurocept.nl

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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