Anpheros Search · Treatment

Tobramycin

Also known as: Tobi Podhaler · Vantobra (previously Tobramycin PARI) · BETHKIS · TOBI · TOBREX

General information only. Anpheros does not diagnose and does not recommend treatment. Talk to a doctor or pharmacist about your situation. In an emergency, call 112 (or your local emergency number).

In short

In the European Union, tobramycin is indicated for the suppressive therapy or management of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. In the United States, tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. The safety and efficacy of the inhalation solution have not been demonstrated in patients under 6 years of age, patients with a forced expiratory volume in 1 second less than 25% or greater than 75% predicted, or patients colonized with Burkholderia cepacia. Tobramycin is listed by the cited source as having an approved use for cystic fibrosis.

From: Source: European Medicines Agency (EMA), Tobi Podhaler — EPAR, 11/05/2026. © European Medicines Agency. · Source: European Medicines Agency (EMA), Vantobra (previously Tobramycin PARI) — EPAR, 05/08/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
10627 tobramycin
EMA
EMEA/H/C/002155, EMEA/H/C/005086

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Tobi Podhaler

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.

Source: European Medicines Agency (EMA), Tobi Podhaler — EPAR, 11/05/2026. © European Medicines Agency.

Document date: 11/05/2026 · Official document →

FDA (USA) TOBRAMYCIN

1 INDICATIONS AND USAGE Tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14) ]. Tobramycin inhalation solution is an aminoglycoside antibacterial indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >75% predicted, or patients colonized with Burkholderia cepacia .

Data provided by the U.S. Food and Drug Administration.

Document date: 20260729 · Official document →

EMA (EU) Vantobra (previously Tobramycin PARI)

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.

Source: European Medicines Agency (EMA), Vantobra (previously Tobramycin PARI) — EPAR, 05/08/2026. © European Medicines Agency.

Document date: 05/08/2026 · Official document →

Related terms in the cited sources

Has an official indication for

In alphabetical order.

Other treatments A–Z

What people report

Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.

How these counts are made →

External resources

Questions

What is Tobramycin approved for in the European Union?

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. (Source: European Medicines Agency (EMA), Tobi Podhaler — EPAR, 11/05/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Data provided by the U.S. Food and Drug Administration.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Tobi Podhaler — EPAR, 11/05/2026. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Vantobra (previously Tobramycin PARI) — EPAR, 05/08/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →