Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: TOBI PODHALER
Active substances:
Tobramycin
Estonian, English, Latin
ATC code: J01GB01
Dosage form: inhalation powder, hard capsule
Strength: 28mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
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 
Assessment report:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Hambaarstil on õigus välja kirjutada
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1553879  TOBI PODHALER  inhalation powder, hard capsule  28mg 56TK  Prescription          inhalaator 1 TK 
1553880  TOBI PODHALER  inhalation powder, hard capsule  28mg 224TK  Prescription  100%    18.01.2024    inhalaator 5 TK 
1553891  TOBI PODHALER  inhalation powder, hard capsule  28mg 448TK  Prescription          inhalaator 10 TK 
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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