Granupas (previously Para-aminosalicylic acid Lucane)

On 4 December 2025, the European Commission withdrew the marketing authorisation for Granupas (aminosalicylic acid) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Eurocept International B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. Granupas was granted marketing authorisation in the EU on 7 April 2014 for use as part of an appropriate combination regimen for multi\-drug\-resistant tuberculosis in adults and paediatric patients from 28 days of age and older, when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. It was then granted unlimited validity in 2018\. The marketing authorisation holder has committed to ensure that patients who need Granupas for the treatment of tuberculosis will continue to receive it on a ‘named\-patient basis’ (when a medicine is obtained directly from the manufacturer for an individual patient, upon doctor’s request.) The European Public Assessment Report (EPAR) for Granupas will be updated to indicate that the marketing authorisation is no longer valid.