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.
Treatment of tuberculosis
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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.
Documents related to this orphan designation evaluation
Recommendation for maintenance of orphan designation at the time of marketing authorisation: Para-aminosalicylic acid Lucane (para-aminosalicylic acid) for the treatment of tuberculosis (PDF/81 KB)
First published: 12/05/2014
Last updated: 16/10/2014
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.
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: