Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Granupas   
Auth. number : EU/1/13/896
INN : Para-aminosalicylic acid
Orphan status based on designation EU/3/10/826 added on 09/04/2014
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J04 - Antimycobacterials
Pharmacological subgroup: J04A - Drugs for treatment of tuberculosis
Chemical subgroup: J04AA - Aminosalicylic acid and derivatives
Chemical substance: J04AA01 - 4-aminosalicylic acid
(See WHO ATC Index)
Indication: 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.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Authorisation Holder: Lucane Pharma
172 rue de Charonne, 75011 Paris, France

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
09/04/2014 Centralised - Authorisation EMEA/H/C/2709 (2014)2444 of 07/04/2014
15/05/2014 Centralised - Variation EMEA/H/C/2709/IAin/3
15/05/2014 Centralised - Variation EMEA/H/C/2709/IAin/5
10/06/2014 Centralised - Variation EMEA/H/C/2709/IB/2
18/06/2014 Centralised - Notification EMEA/H/C/2709/N/7