Tobi Podhaler (tobramycin)
- Region
- 🇪🇺 EU
- Active substance
- tobramycin
- Company
- Viatris Healthcare Limited
- Status
- Authorised
- Therapeutic area
- Cystic Fibrosis; Respiratory Tract Infections
- CHMP opinion
- Thu 23 Sep 2010
- EU approval
- Wed 20 Jul 2011
- Application
- EMEA/H/C/002155
- ATC
- J01GB01
- Official record
- www.ema.europa.eu
Indication
Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups. 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
- 🇪🇺 Vantobra (previously Tobramycin PARI) Authorised · Pari Pharma GmbH
- 🇪🇺 Vantobra Withdrawn · Pari Pharma GmbH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.