Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1553880
Name of medicinal product: TOBI PODHALER
Active substances:
Tobramycin
Estonian, English, Latin
ATC code: J01GB01
Dosage form: inhalation powder, hard capsule
Route of administration: inhalation use
Strengh: 28mg
Amount in package: 224TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information: inhalaator 5 TK
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.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: January 18, 2024
Marketing authorization holder: VIATRIS HEALTHCARE Limited 
Marketing authorization number: EU/1/10/652 
Marketing authorization issued on: July 20, 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  01.01.2024     Yes  E84-E84  Pediaater, Pulmonoloog  No  until 4 years  Pseudomonas aeruginosa põhjustatud kroonilise kopsuinfektsiooni supressiivseks raviks tsüstilise fibroosiga patsientidel 
100  01.01.2024     Yes  E84-E84  Pulmonoloog, Pediaater  No     Pseudomonas aeruginosa põhjustatud kroonilise kopsuinfektsiooni supressiivseks raviks tsüstilise fibroosiga patsientidel 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Hambaarstil on õigus välja kirjutada
Entry/Changing date: September 7, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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