Product class:
|
Authorized package
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Medicinal product class:
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For human use
|
Package code:
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1789656
|
Name of medicinal product:
|
VANTOBRA
|
Active substances:
|
|
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*:
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Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
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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:
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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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