Granupas (previously Para-aminosalicylic acid Lucane)

Withdrawn

This medicine's authorisation has been withdrawn

para-aminosalicylic acid

Overview

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European Public Assessment Report (EPAR) for Granupas will be updated to indicate that the marketing authorisation is no longer valid.

Granupas : EPAR - Summary for the public

Reference Number: EMA/746926/2013

Product information

Granupas : EPAR - Product Information

Granupas : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Granupas (previously Para-aminosalicylic acid Lucane)
• Active substance:
  para-aminosalicylic acid
• International non-proprietary name (INN) or common name:
  para-aminosalicylic acid
• Therapeutic area (MeSH):
  Tuberculosis
• Anatomical therapeutic chemical (ATC) code:
  J04AA01

Pharmacotherapeutic group

Antimycobacterials

Therapeutic indication

Granupas is indicated 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 (see section 4.4).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Authorisation details

• EMA product number:
  EMEA/H/C/002709
• Marketing authorisation holder:
  Eurocept International B. V.

  Trapgans 5; 1244 RL Ankeveen; The Netherlands

• Opinion adopted:
  21/11/2013
• Marketing authorisation issued:
  07/04/2014
• Withdrawal of marketing authorisation:
  04/12/2025
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

Granupas : EPAR - Procedural steps taken and scientific information after authorisation

Granupas-H-C-PSUSA-00010171-202110 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/816905/2022

Initial marketing authorisation documents

Para-aminosalicylic acid Lucane : EPAR - Public assessment report

Adopted Reference Number: EMA/18511/2014

CHMP summary of positive opinion for Para-aminosalicylic acid Lucane

Adopted Reference Number: EMA/CHMP/709518/2013