Vantobra (previously Tobramycin PARI) (tobramycin)
- Region
- 🇪🇺 EU
- Active substance
- tobramycin
- Company
- Pari Pharma GmbH
- Status
- Authorised
- Therapeutic area
- Respiratory Tract Infections; Cystic Fibrosis
- EU approval
- Mon 18 Feb 2019
- Application
- EMEA/H/C/005086
- ATC
- J01GB01
- Official record
- www.ema.europa.eu
Indication
Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tobi Podhaler Authorised · Viatris Healthcare Limited
- 🇪🇺 Vantobra Withdrawn · Pari Pharma GmbH
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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.