Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Granupas   
Auth. number : EU/1/13/896
Active substance : Para-aminosalicylic acid
Orphan market exclusivity for "Treatment of tuberculosis" (based on designation EU/3/10/826) started on 09/04/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 09/04/2024
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/5
Updated with Decision(2015)3424 of 13/05/2015
15/05/2014 Centralised - Variation EMEA/H/C/2709/IAin/3
Updated with Decision(2015)3424 of 13/05/2015
10/06/2014 Centralised - Variation EMEA/H/C/2709/IB/2
Updated with Decision(2015)3424 of 13/05/2015
18/06/2014 Centralised - Notification EMEA/H/C/2709/N/7
Updated with Decision(2015)3424 of 13/05/2015
19/05/2015 Centralised - Yearly update (2015)3424 of 13/05/2015
26/05/2016 Centralised - Variation EMEA/H/C/2709/II/13
Updated with Decision(2016) 4923 of 22/07/2016
21/07/2016 Centralised - Variation EMEA/H/C/2709/II/14
Updated with Decision(2017) 5358 of 25/07/2017
26/07/2016 PSUSA - Modification EMEA/H/C/2709/PSUSA/10171/201510 (2016) 4923 of 22/07/2016
18/04/2017 Centralised - Notification EMEA/H/C/2709/N/20
Updated with Decision(2017) 5358 of 25/07/2017