Granupas (previously Para-aminosalicylic acid Lucane)

RSS

para-aminosalicylic acid

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Granupas. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Granupas.

For practical information about using Granupas, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 17/07/2018

Authorisation details

Product details
Name
Granupas (previously Para-aminosalicylic acid Lucane)
Agency product number
EMEA/H/C/002709
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
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Eurocept International B. V.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
06/04/2014
Contact address
Trapgans 5
1244 RL Ankeveen
The Netherlands

Product information

28/06/2018 Granupas (previously Para-aminosalicylic acid Lucane) - EMEA/H/C/002709 - T/0025

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

How useful was this page?

Add your rating