🇪🇺 Para-Aminosalicylic Acid in European Union

EMA authorised Para-Aminosalicylic Acid on 7 April 2014

Marketing authorisation

EMA — authorised 7 April 2014

  • Application: EMEA/H/C/002709
  • Marketing authorisation holder: Eurocept International B. V.
  • Local brand name: Granupas (previously Para-aminosalicylic acid Lucane)
  • 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.
  • Status: withdrawn

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Para-Aminosalicylic Acid in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Para-Aminosalicylic Acid approved in European Union?

Yes. EMA authorised it on 7 April 2014.

Who is the marketing authorisation holder for Para-Aminosalicylic Acid in European Union?

Eurocept International B. V. holds the EU marketing authorisation.