Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1646827
Name of medicinal product: TOBRAMYCIN VIA PHARMA
Active substances:
Tobramycin
Estonian, English, Latin
ATC code: J01GB01
Dosage form: nebuliser solution
Route of administration: inhalation use
Strengh: 300mg 5ml
Amount in package: 56TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Long-term management of chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated March 31, 2021)
Package information leaflet (PIL): EST  (last updated March 31, 2021)
Labelling:  (last updated March 31, 2021)
Last imported to Estonia: February 15, 2024
Marketing authorization holder: Via Pharma UAB 
Marketing authorization number: 911916 
Marketing authorization issued on: June 7, 2016 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
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  Pediaater, Pulmonoloog  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: April 14, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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