Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1789656
Name of medicinal product: VANTOBRA
Active substances:
Tobramycin
Estonian, English, Latin
ATC code: J01GB01
Dosage form: nebuliser solution
Route of administration: inhalation use
Strengh: 170mg 1.7ml
Amount in package: 1.7ml 56TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: 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.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Pari Pharma GmbH 
Marketing authorization number: EU/1/18/1350 
Marketing authorization issued on: February 20, 2019 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
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: January 10, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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