Medicinal Products

Braltus 10 mikrograma po isporučenoj dozi, prašak inhalata, tvrde kapsule

Name Braltus 10 mikrograma po isporučenoj dozi, prašak inhalata, tvrde kapsule
Marketing Authorisation Number HR-H-818206056
Active Substance tiotropijev bromid
Composition jedna kapsula sadrži 16 mikrograma tiotropijevog bromida što odgovara 13 mikrograma tiotropija jedna doza sadrži 10 mikrograma tiotropija po kapsuli
Pharmaceutical Form prašak inhalata, tvrda kapsula
Packaging [MA Number for Packaging] 15 kapsula u bočici i 1 inhalator, u kutiji   [HR-H-818206056-01]
30 kapsula u bočici i 1 inhalator, u kutiji  [HR-H-818206056-02]
60 kapsula (2 bočice od 30 kapsula) i 2 inhalatora, u kutiji  [HR-H-818206056-03]
90 kapsula (3 bočice od 30 kapsula) i 3 inhalatora, u kutiji  [HR-H-818206056-04]
30 kapsula u bočici u kutiji i 1 inhalator u kutiji  [HR-H-818206056-05]
Manufacturer Laboratorios Liconsa S.A., Azuqueca de Henares, Guadalajara, Španjolska
Teva Pharma B.V., Haarlem, Nizozemska
Actavis Limited, Zejtun, Malta
Teva Operations Poland Sp. z o.o., Krakow, Poljska
Marketing Authorisation Holder Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska
Marketing Authorisation Date 24.02.2021
MA Period of Validity unlimited
Classification Number UP/I-530-09/20-02/135
Registration Number 381-12-01/154-21-05
Prescription na recept
Type of prescription ponovljivi recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code R03BB04
Medicinal product marketed in the Croatia Da
SmPC download
PL download
Public Assessment Report download
Educational materials
for healthcare professionals
Vodič za zdravstvene radnike, verzija 1
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