Granupas (previously Para-aminosalicylic acid Lucane) (para-aminosalicylic acid)
- Region
- 🇪🇺 EU
- Active substance
- para-aminosalicylic acid
- Company
- Eurocept International B. V.
- Status
- Withdrawn
- Therapeutic area
- Tuberculosis
- CHMP opinion
- Thu 21 Nov 2013
- EU approval
- Mon 07 Apr 2014
- Application
- EMEA/H/C/002709
- ATC
- J04AA01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Follow Granupas (previously Para-aminosalicylic acid Lucane)
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.