Granupas (previously Para-aminosalicylic acid Lucane)
para-aminosalicylic acid
Table of contents
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.
Authorisation details
Product details | |
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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 | |
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Marketing-authorisation holder |
Eurocept International B. V.
|
Revision |
11
|
Date of issue of marketing authorisation valid throughout the European Union |
07/04/2014
|
Contact address |
Trapgans 5 |
Product information
18/04/2023 Granupas (previously Para-aminosalicylic acid Lucane) - EMEA/H/C/002709 - N/0039
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.