Tobramycin PARI

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tobramycin

Authorised
This medicine is authorised for use in the European Union.

Overview

Tobramycin PARI is an antibiotic used for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged six years and older who have cystic fibrosis.

Cystic fibrosis is an inherited disease in which thick mucus builds up in the lungs that allows bacteria to grow more easily, causing infections. P. aeruginosa is a frequent cause of infections in cystic fibrosis patients.

Tobramycin PARI is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, tobramycin; however Tobramycin PARI has a higher amount of the active substance. The reference medicine for Tobramycin PARI is Tobi.

This EPAR was last updated on 17/04/2019

Authorisation details

Product details
Name
Tobramycin PARI
Agency product number
EMEA/H/C/005086
Active substance
Tobramycin
International non-proprietary name (INN) or common name
tobramycin
Therapeutic area (MeSH)
  • Respiratory Tract Infections
  • Cystic Fibrosis
Anatomical therapeutic chemical (ATC) code
J01GB01
Publication details
Marketing-authorisation holder
Pari Pharma GmbH
Date of issue of marketing authorisation valid throughout the European Union
18/02/2019
Contact address

Moosstrasse 3
82319 Starnberg
Germany

Product information

18/02/2019 Tobramycin PARI - EMEA/H/C/005086 -

Contents

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Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Tobramycin PARI 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.

Assessment history

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